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APPENDIX

Rehabilitation Tool for Traumatic Brain Injury Patients

Appendix Table of Contents:

Design safe----------------------------------------------------------------ii

Innovative Workbench----------------------------------------------iii-x

IRB protocol----------------------------------------------------------xi-xiii

IRB consent form--------------------------------------------------xiv-xvi

IRB proposal----------------------------------------------------xvii-xxxiv

Volunteer consent form------------------------------------------xxxvi

Volunteer post-evaluation survey----------------------xxxvi-xxxvii

Session 2 of COGsmart Manual of the VA---------------xxxix-xlvi

Design Safe:Application: TBI Rehabilitation Coach

Description:

Product Identifier:

Assessment Type: Detailed

Limits:

Sources:

Guide sentence: When doing [task], the [user] could be injured by the [hazard] due to the [failure mode].

Analyst Name(s): David Weinberg & Erwin Yap

Company: Vanderbilt Senior Design Group 11

Facility Location: Nashville, TN

Initial Assessment Final AssessmentSeverity Severity Status /

User / Hazard / Exposure Exposure ResponsibleRisk Reduction Methods

Task Failure Mode Probability Risk Level /Comments Probability Risk Level /ReferenceAll :Users mechanical : fatigue Minimal Moderate standard procedures On-going [Monthly]

All Tasks Occasional Possible

All UsersElectrical / electronic : water / wet locations Minimal Moderate standard procedures On-going [Monthly]

All Tasks OccasionalPossible

All Users Software may freeze/crash Minimal Moderate standard procedures On-going [Monthly]All Tasks

set-up person ergonomics / human factors : Minimal Moderate standard procedures On-going [Daily]

set-up or changeover lifting / bending / twisting FrequentPossible

set-up person None / Other : Not a hazardperiodic maintenance

set-up person None / Other : Not a hazardinstallation

engineer None / Other : Not a hazardconduct tests

Page 1

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Innovative Workbench:

Ideation ProcessProject Initiation

Project Name: Rehabilitation Database for Traumatic Brain Injury Patients

Project Timeline: October 29, 2009- April 21, 2010

ID

Task Name Duration Start Finish Predecessors

1 NCIIA Proposal Due 1 day 29-Oct 29-Oct

2 Written/Oral Report 1 day 4-Nov 4-Nov

3 Optics Background Reading 7 days 4-Nov 12-Nov

4 Written/Oral report 1 day 10-Nov 10-Nov

5 Written/Oral Report 1 day 17-Nov 17-Nov

6 Begin electronic reference pages 1 day 19-Nov 19-Nov

7 IWB w/conflict map and expansion 1 day 20-Nov 20-Nov

8 Background of problem 25 days 20-Nov 15-Dec

10

TBI Research 25 days 15-Dec 9-Jan

11

Current technique observation 10 days 9-Jan 19-Jan

12

Preliminary Design of Tool 30 days 19-Jan 18-Feb 9, 10, 11

13

Preliminary testing of tool 15 days 18-Feb 5-Mar 12

14

Team meetings to discuss improvements 10 days 5-Mar 15-Mar

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15

Redesign of tool 20 days 15-Mar 4-Apr 13

16

Testing of new design 10 days 4-Apr 14-Apr 15

17

Finalize report 7 days 14-Apr 21-Apr

18

Final project due 1 day 21-Apr 21-Apr

Project Team: David Weinberg (david.a.weinberg@vanderbilt.edu), Erwin Yap (erwin.r.yap@vanderbilt.edu), and our advisor Dr. Joseph Cheng (joseph.cheng@vanderbilt.edu)

1. Project objectives

1. Design a learning tool which can help improve short term memory for patients ages 21-40 with traumatic brain injury.

2. Integrate an easy-to-use visualizing interface with a database to keep track of the patients’ day-to-day progress.

3. These objectives were processed a month ago and do not need to be updated at this time.

4. Provide feedback depending on the speed and accuracy of the users. Erwin and I have not overestimated our capabilities and Dr. Cheng is present to help us along the way. He has a tremendous experience dealing with TBI patients.

2. Importance of the Situation

1. TBI patients, independent living homes, freeware, Quality of Life Technology (QoLT)

2. Neural Pathways can be modified and created with practice and repetition.

3. If this situation is not improved, extreme frustration could ignite depression in TBI patients. The only other way to overcome this is with good oversight (from a family member or caretaker) and education.

4.Yes, human lives are vital.

5.The information we have obtained about previous rehabilitation methods is not overwhelming. There have been some breakthroughs with 3D virtual environments for improving problem solving skills and attention. Dr. Cheng and other neuroscience specialists have given us valuable advice, which we are using to narrow down our project goals into a few foci.

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6. TBI rehabilitation could prevent isolation from the community, as well as employment and educational opportunities.

Innovation Situation Questionnaire

1. Brief description of the situation

A large force or impact on the head can cause brain damage. TBI is the major cause of disability worldwide and occurs when an outside force traumatically injures the brain. Impaired working memory, damaged executive function, confusion and forgetfulness are results of TBI. This can be detrimental to long-term memory formation.

2. Detailed description of the situation

Traumatic Brain Injury is damage to the brain resulting from external mechanical forces like rapid acceleration, impact, blast waves or projectile, which causes brain function to be permanently or temporarily impaired. TBI is one of the two subsets of acquired brain injury; the other one is caused by non-external forces like stroke and infection.

Impaired working memory, damaged executive function, confusion and forgetfulness are results of TBI. Brain injury rehabilitation involves two processes: restorations of functions that can be restored and learning how to do things differently when functions cannot be restored to pre-injury level.

Successful visualization and database interaction will improve working memory, and thus, improve long-term memory formation.

2.1. Supersystem - System - Subsystems

2.1.1. System name

Web visualization interface (Flash or Alice based)

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2.1.2. System structure

The interactive rehabilitation tool will act as a teleprompter with the assumption that affected patients still have an implicit memory. By providing a step-by-step simulation of a task, neurons in their brain are stimulated to help them remember previously held motor and sensory functions. The database will store patients’ information and track their learning. They can go back to where they previously stopped. The tool will provide feedback based on the patient’s strength and weaknesses. This method is better than the paper manual method because patients get to visualize and apply hands-on product assembly and have more time in areas of concern. This tool will help patients go back to their pre-injury lives and be competitive in the job market by having relearned skills.

2.1.3. Supersystems and environment

A computer will be needed, requiring internet access.

2.1.4. Systems with similar problems

2.2. Input - Process - Output

The system inputs are transferred into outputs though a computer program (probably Alice+SQL or Flash+PHP+SQL). The problem is correct communication between the database and the users input on the visualizer. Thus, the inputs are numerical (time sensitive) and can be warped if the rehab tool user is idle or leaves the computer.

2.2.1. Functioning of the system

The system works by POST and GET functions with PHP, which acts as a go-between for database / visualization interaction.

2.2.2. System inputs

Currently, the system input will be the user clicking ‘Step completed’ button or clicking on an appropriate object testing there short-term memory for the preliminary criteria tests (MMSE).

2.2.3. System outputs

The main system output is a database, which will provide reports on our website (http://engssws.vuse.vanderbilt.edu/sdp/tbi)

2.3. Cause - Problem - Effect

The criteria we will require are that they have short-term memory impairment. We do not want to take on attention deficit TBI patients.

2.3.1. Problem to be resolved

The problem to be resolved is the differentiation between short-term memory and attention

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impairment.

2.3.2. Mechanism causing the problem

Lower harmful parameters

Enhance useful parameters

Reliability

Universality

Counteract the harmful effect

There are no events that correspond with the problem.

Time wasted (utilize time resources)

Cost

A computer, with access to the internet, is required. The program itself will be freeware, which is free to use and share. The program will be universally accessible. The hypothesis of our project is that our rehabilitation tool is better in helping memory improvement compared to conventional tools like a paper manual.

2.3.3. Undesirable consequences if the problem is not resolved

If the problem remains unresolved, the TBI patient could be put in harm’s way by depression, job loss, physical or emotional damage. Not treating the problem has negative repercussions for the TBI patients.

2.3.4. Other problems to be solved

2.4. Past - Present - Future

The current system is under study and is not an FDA approved system. The current system is a time diary or personal device assistant used to write reminders and check off daily routines. These written tools have become digitized using electronics, but they are not universally accessible nor are there enough studies looking at the effectiveness. Hopefully, our rehab tool will change the system in the future. It will be easy to use. It will also provide weekly reports showing progress for different activities, and each step involved in an activity. In the future, the system might be used as an educational tool for people of all ages, or a commercial tool to be used at a Wal-Mart or McDonalds. The problem arised when TBI patients lose their employment because they could not perform at the same level they once were before injury. If the problem goes unresolved, TBI patients will become isolated from society, and will be depressed. TBI is a sudden occurrence and hard to prevent (wear a helmet while riding a bicycle etc).The only way to deal with the memory impairments from a brain injury is to be closely monitored in the rehabilitation tasks.

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2.4.1. History of the problem

The sudden onset of traumatic brain injury is a stealer of normal livelihood. TBI is the major cause of disability and death worldwide. TBI occurs in falls (28%), car accidents (20%), struck by events (19%) and assaults (11%). TBI can happen to anyone and can happen in all age groups. Impaired working memory, damaged executive function, confusion and forgetfulness are results of TBI. Brain injury rehabilitation involves two processes: restorations of functions that can be restored and learning how to do things differently when functions cannot be restored to pre-injury level.

2.4.2. Pre-process time

A required system function cannot be carried out beforehand to help resolve the problem.

2.4.3. Post-process time

A required system function cannot be carried out afterhand to help resolve the problem.

3. Resources, constraints and limitations

3.1. Available resources

Substance resources: Server with PHP and SQL installed (or Alice). (http://engssws.vuse.vanderbilt.edu/sdp/tbi)

Space resources: The user, chair, keyboard, monitor, mouse, and computer

Time resources: Criteria test, step-by-step assembly, Report

Informational resources: The time between steps, as well as the accuracy of the step completed.

Functional resources: Identification of memory improvement from a baseline tool.

3.2. Allowable changes to the system

2. Far-reaching changes to the system are permitted.

3.3. Constraints and limitations

1. Server bandwidth we have been provided will not be able to support hundreds of thousands of people logged in at once. We do not plan having that much users. For our project, the amount of users we will give access to will be able to log in all at once.

3.4. Criteria for selecting solution concepts

Finished rehab tool should accurately distinguish between the negative and positive feedback for the speed of the visualizer at least 90% of the time.

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AccuratelyDifferentiat

esMemory improvement Between our tool and

control

Increase in AccuracyFor our tool Over time Short-

termMemory is improved

Time betweenSteps

decreasedOver time with ourRehab

tool

Long-termMemory formationIs improved.

Time and mentalState can beworsened

MemoryIs not

improved

Our tool andA baseline toolYield similar result

s

Problem Formulation and BrainstormingGroup10

12/7/2009 10:04:22 AM.

2. Find an alternative way to obtain time between steps in an assembly process that provides or enhances Accurately Differentiates memory improvement between our rehab tool and a control.

6. Find a way to eliminate, reduce, or prevent data entry when the user if idle or away from the computer, or clicks ‘step completed’ over and over again in a short amount of time. under the conditions of false data.

Develop Concepts1. Categorize preliminary ideas

Reduced time between assembly steps indicates improved short-term memory. Must develop a way to speed up visualizations for assembly when user needs less assistance, and slow down the visualizations when the user needs a push in the right direction:

1) Idea: Let the user go through ten cycles or so before we have baseline times between steps.

Short-coming: Visualization has to be clear and easy enough for the user to be able to repeat the process with no further questions asked.

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2) Idea: Numeric value indication relative to time between steps.

Short-coming: Evaluation of progress could be time-consuming, and unclear on how many seconds is normal for someone with normal brain function.

3) Idea: Could set a threshold value, such that if the step is not completed by a certain amount of time, the visualization tool pauses and gives the option to restart that step.

Short-coming: How much time is needed for the threshold value, what if the user is just really slow? Can we distinguish between someone idling and someone just taking their time?

2. Combine ideas into concepts

The short-comings of the visualization tool are different from those of previous rehabilitation tools. Using a combination of visualization with positive and negative feedback, time between steps could be an operator to show whether or not memory can be improved.

Evaluate Results1. Meet criteria for evaluating Concepts

2. Reveal and prevent potential failures

3. Apply Patterns/Lines of Evolution

4. Plan the implementation

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IRB protocol draft:

Table of Contents:

Study Schema

1.0 Background2.0 Rationale and Specific Aims3.0 Animal Studies and Previous Human Studies4.0 Inclusion/Exclusion Criteria5.0 Enrollment/Randomization6.0 Study Procedures7.0 Risks of Investigational Agents/Devices (side effects)8.0 Reporting of Adverse Events or Unanticipated Problems involving

Risk to Participants or Others9.0 Study Withdrawal/Discontinuation10.0 Statistical Considerations11.0 Privacy/Confidentiality Issues12.0 Follow-up and Record Retention

Appendices

Appendix AStudy Procedure Calendar

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Background

The Defense Department estimates that approximately 20% of soldiers have suffered TBI. [1]According to the CDC, 1.4 million Americans experience TBI each year, 50,000 of which die. The CDC also reports that an estimated 5.3 million Americans live with disabilities caused by TBI. Disabilities due to TBI causes lost of productivity and life. TBI damage ranges from mild to severe and from attention deficit to memory loss.

1.0 Rationale and Specific Aims

1. Help the TBI patients become competitive in the job market after the injury. 2. Analyze patients’ strengths and weaknesses. 3. Focus on the steps of concern by adding more details and automatically provide feedback to the users.4. Develop technology into both an educational and a commercial tool. 5. Improve memory from a neural standpoint.

2.0 Animal Studies and Previous Human StudiesDescribe the process and outcome of the animal and/or laboratory studies that have been done. Also, if any previous human studies have been done (e.g., Phase I, other phases maybe in a different population or for a different indication).

3.0 Inclusion/Exclusion Criteria

List the criteria:

21-40 years old Patients with mild traumatic brain injury Served in the army for at least 6 months

4.0 Enrollment/RandomizationList the process for randomization and/or registration; list the address, phone number or website where the registration will take place.

5.0 Study ProceduresIf multiple experiments are to be done, describe each separately. Include all interventions, experimental manipulations, data collection procedures, and measurements.

List the days and time frame of the study. Begin with Day 1, 0, or describe a wash out period if applicable.Day 1: H&P, CBC, SMA7, ECG, etc.

Day 2: Administer study drug, etc.

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Provide a description of what the participants will experience. For example, a description of the instructions that will be given to the participants, activities in which they will engage, the length and timing of involvement, and the circumstances under which they will provide data (e.g., phone calls, spending time in an uncomfortable position, group assessments, one-on-one interview, videotaping, audiotaping, etc.)

6.0 RisksThere are no risks associated with this study.

7.0 Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or Others

There are no unanticipated risks associated with this study.

8.0 Study Withdrawal/DiscontinuationThe subject may withdraw from the study at any point during the clinical trial.

9.0 Statistical ConsiderationsDescribe the statistical power of the study, the confidence intervals and the method for analysis. Describe any possible deviations and their statistical impact.

10.0 Privacy/Confidentiality IssuesSubjects will be given subject numbers. Results will be linked to the subject number. No names will be collected.

11.0 Follow-up and Record RetentionThe study will take no longer than 10 minutes. The subject will be watched while participating in the study. Results will be recorded by the researcher.

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IRB consent form draft:

This informed consent applies to mild traumatic brain injury patients ages 21-40.

Name of participant: _________________________________________________________ Age: ___________

The following is given to you to tell you about this research study. Please read this form with care and ask any questions you

may have about this study. Your questions will be answered. Also, you will be given a copy of this consent form.

You do not have to be in this research study. You can stop being in this study at any time. If we learn something new that

may affect the risks or benefits of this study, you will be told so that you can decide whether or not you still want to be in

this study.

1. What is the purpose of this study?

You are being asked to take part in this research study because we believe we can help TBI patients regain competence in the job market by guiding them to regain executive skills. We plan to improve their memory by doing specific tasks. Our tool can also be used as a good neuro-rehabilitation evaluation to determine the extent of injury.

2. What will happen and how long will you be in the study?

You will be tasked to watch a video on making a burger or setting up a table. An instruction screen will show up which will let you determine the difficulty level you want the video to be shown. The difficulty will determine the rate the which the video will be presented. After the video, you will be tasked to complete the task using the model provided. You will be evaluated by your performance on the task.

3. Costs to you if you take part in this study:

There is no cost to you for taking part in this study.

4. Side effects and risks that you can expect if you take part in this study:

Dizziness and frustration might occur to you during this study.

5. Risks that are not known:

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There are no known risks for participating in this study.

6. Payment in case you are injured because of this research study:

There are no plans for Vanderbilt to pay for the costs of any additional care. There are no plans for Vanderbilt to give you money for the injury.

7. Good effects that might result from this study:

a) The benefits to science and humankind that might result from this study.

b) As a beta test volunteer, you are involved with research that might help improve the rehabilitation process for traumatic brain injury patients.

8. Other treatments you could get if you decide not to be in this study:

a) Attend a traumatic brain injury class.b) Practical Exercisesc) Use of datebooks

9. Payments for your time spent taking part in this study or expenses:

$$$

10. Reasons why the study doctor may take you out of this study:

If we feel you are incompetent in achieving the tasks assigned or your injury is beyond the limitations we are trying to treat.

11. What will happen if you decide to stop being in this study?

If you decide to stop being part of the study, you should tell your study doctor.

12. Who to call for any questions or in case you are injured:

If you should have any questions about this research study or if you feel you have been hurt by being a part of this study, please feel free to contact David Weinberg at 401-575-3626 or my Faculty Advisor, Dr. Joseph Cheng at 615-322-7417.

For additional information about giving consent or your rights as a person in this study, please feel free to call the Vanderbilt University Institutional Review Board Office at (615) 322-2918 or toll free at (866) 224-8273.

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13. Confidentiality:

Results will be kept confidential. No names will be associated with the sample. All results will stay in one computer.

If you decide not to take part in this research study, it will not affect your treatment, payment or

enrollment in any health plans or affect your ability to get benefits. You will get a copy of this form after

it is signed.

STATEMENT BY PERSON AGREEING TO BE IN THIS STUDY

I have read this consent form and the research study has been explained to me verbally. All my questions have been answered, and I freely and voluntarily choose to take part in this study.

Date Signature of patient/volunteer

Consent obtained by:

Date Signature

Printed Name and Title

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IRB proposal draft:

Vanderbilt University Institutional Review Board

Application for Human Research

Health Sciences

1. Is this proposal associated with any other IRB-approved studies?

X No

Yes If “Yes”, please list IRB #(s):

     

2. Location of ResearchA. Is this a multi-center trial?

X No

Yes

B. Is this a multi-center trial in which Vanderbilt will function as the coordinating center? (A multi-

center study is one where different PIs at different institutions are conducting the same study).

X No

Yes If “Yes,” please complete the Coordinating Center Supplemental Form (Form #1132)

C. List all Performance Sites “engaged in research” (insert additional rows if needed)

An institution or performance site is “engaged in research” when its employees or agents (i) intervene or interact with living individuals for research purposes; (ii) obtain individually identifiable private information for research purposes; or (iii) if the institution receives a direct federal award to support such research. This may apply when a VU investigator collaborates with a non-VU investigator or institution, or when VU serves as a Coordinating Center. Please check all that apply and add additional sites. Each will require a letter of IRB approval. See IRB Policy IRB Policy I.C.

Check all that apply

Name of Performance Site (list all participating sites below)

FWA Holding Institution IRB of Record IRB Approval

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X Vanderbilt University (indicate where at VU): Biomedical Engineering Department

      VU

Other

Attached

Pending

Vanderbilt Stallworth Rehabilitation Hospital

      VU

Other

Attached

Pending

University Community Health Services (Vine Hill Clinic)

      VU

Other

Attached

Pending

International Epidemiology Institute       VU

Other

Attached

Pending

Owensboro Medical Health System       VU

Other

Attached

Pending

The Jones Clinic       VU

Other

Attached

Pending

Purchase Cancer Center       VU

Other

Attached

Pending

Faith Family Medical Clinic       VU

Other

Attached

Pending

Other, specify:             VU

Other

Attached

Pending

Other, specify:             VU

Other

Attached

Pending

Other, specify:             VU

Other

Attached

Pending

D. List all Performance Site(s) not engaged in research (insert additional rows if needed) NA

An institution or performance site is considered “not engaged in research” when its employees or agents do not (i) intervene or interact with living individuals for research purposes; or (ii) does not obtain individually identifiable private information for research purposes; or (iii) if the institution does not receive a direct federal award to support such research. This applies if a VU investigator will be conducting research at a non-VU site or institution (e.g., when collecting specimens or information). Please refer to the instructions for examples of what may be considered “not engaged in research.” See IRB Policy I.C.

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Name of Performance Site If the Performance Site has an IRB, a copy of the IRB approval letter is

required.

If the Performance Site does not have an IRB, a letter of cooperation

is required.

      Attached

Pending

Attached

Pending

      Attached

Pending

Attached

Pending

      Attached

Pending

Attached

Pending

      Attached

Pending

Attached

Pending

      Attached

Pending

Attached

Pending

      Attached

Pending

Attached

Pending

3. Additional VU Committee Approvals (check all that apply): NA

*Institutional BioSafety Committee (IBC) Approval Date:      

*Radioactive Drug Research Committee (RDRC) Approval Date:      

Scientific Review Committee (SRC) Approval Date:      

*Copy of approval letter required before final IRB approval will be extended.

4. Funding Information

A. Internal Funding (check all that apply):

Departmental Funds X No cost study Personal Funds

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Various Donors/Gifts Other, specify:      

B. External Funding (list all that apply; insert additional rows if needed):

Agency/Sponsor Funding Mechanism

      Grant Contract      Grant Contract      Grant Contract      Grant Contract      Grant Contract      Grant Contract

C. Is this study Industry-Supported? (If so, it is expected that the sponsor will pay the IRB new study fee of $2250 for initial review.)

No Yes If “Yes”, please indicate method of payment below.

For VU/VUMC:

Please charge my account as follows:Center Number:       Account Number:      

X Center and Account Number Pending—I will forward to the IRB when established.

Request for Waiver of IRB Fees attached—see application instructions.

For VSRH, IEI or other non-Vanderbilt sites, payment is required as specified in the signed MOU:

I have attached a check payable to the “VU IRB” in the amount of $2250.

Check requested – I will forward to the IRB when received

5. Purpose of the Study. X Phase I Phase II Phase III Phase IV N/A (not a drug development trial)Note: For Phase I and Phase I/II studies with therapeutic intent, please also attach the Phase I and Phase I/II Supplemental form, IRB Form # 1143.

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Phase I/II Phase II/III (Note: If more than one phase will be conducted under this application, then separate Informed Consent Documents and Clinical Trial Patient Costs Templates should be submitted for each phase. Use the Multiple Arms/Aims option in FACTr for the billing plan)

Describe the specific scientific objectives of the proposed research in language understandable to the IRB committee members. The IRB Committees are comprised of scientists with varied backgrounds, non-scientists, and community members.

Include the expected duration of the study.

     

6. Description of the Study.

A. Describe the following:

TBI background information

The Defense Department estimates that approximately 20% of soldiers have suffered TBI. [1]According to the CDC, 1.4 million Americans experience TBI each year, 50,000 of which die. The CDC also reports that an estimated 5.3 million Americans live with disabilities caused by TBI. Disabilities due to TBI causes lost of productivity and life. TBI damage ranges from mild to severe and from attention deficit to memory loss.

Project Objective

The purpose of our project is to help TBI patients regain competence in the job market by guiding them to regain executive skills. We plan to improve their memory by doing specific tasks. We will have a virtual video showing the steps which can be modified to suit the individual’s needs. We will then have a model of the video where the patient can implement the learned task.

Our tool can also be used for neuro-rehabilitation evaluation. It can evaluate the extent of TBI injury depending on the patient’s performance on the task.

Common symptoms of Mild Traumatic Brain Injury:

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1. Speech problems2. Weaken comprehension3. Decreased short term memory 4. Attention deficit 5. Sequencing problems

B. Third party coverage eligibility (check one or more as applicable):

Federally funded or supported by centers or cooperative groups that are funded federally (NIH, CDC, AHRQ, DOD and VA)

Conducted under an IND application reviewed by the FDA

Exempt from requiring an IND

X None of the above

C. Therapeutic Intent (check one):

The clinical trial has no therapeutic intent; it is designed to exclusively test toxicity or disease pathophysiology.

X The clinical trial has therapeutic intent* or the trial is testing diagnostic interventions and is enrolling healthy patient as a control group.

*A trial has therapeutic intent when the clinical trial protocol provides for the discovery, measurement, or verification of an effect of an investigational intervention on a participant with a diagnosed disease to determine whether the investigational intervention potentially improves the health outcomes for the participant. The trial must not be designed exclusively to test toxicity or disease pathophysiology. (Note: Studies involving only healthy volunteers would not qualify, as no improved health outcomes are expected for healthy volunteers.)

If there is therapeutic intent in the clinical trial, please provide a brief narrative (and a reference to the section in the protocol) describing how the protocol design supports the above description of of therapeutic intent for the individual participant:      

This is not a clinical trial (An expanded definition is available in the application instructions).

7. Schedule of Events and Research Procedures for Study Participants

A. Will there be costs generated in this study at Vanderbilt?

(Examples: Any tests, interventions, and/or procedures that are billed to a D&H account, patient insurance, sponsor, departmental funds, or other 3rd party.

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Yes If “Yes,” complete the billing plan in FACTr. This system is provided by the Department of Finance. Please contact the Department of Finance for questions on FACTr.

No If “No,” attach a completed Research Procedure Supplemental Form #1140 in DISCOVR-E.

X N/A There are no procedures that involve interaction or intervention with participants or generate costs in this study (e.g., data collection/analysis only, chart review).

B. Will there be costs generated in this study at non-Vanderbilt sites?

(Examples: Enrollment at VICCAN affiliated sites where the VU IRB is the IRB of record; Vanderbilt is the coordinating center but there will be no accrual at Vanderbilt; any tests, interventions, and procedures done at non-Vanderbilt sites and the VU IRB is the IRB of record.)

Yes If “Yes,” attach a completed Research Procedure Supplemental Form #1140 in DISCOVR-E.

X No.

8. Subject Population(s)A. Age range of participants.

21-40

Are you enrolling a population that includes Medicare beneficiaries?

X No

Yes

Medicare is for people 65 years or older, all ages of persons with End-Stage Renal Disease. End-Stage Renal Disease means permanent kidney failure requiring dialysis or kidney transplant. People that are under age 65 with certain disabilities may be eligible if they have received Social Security Retirement Board disability benefits for 24 months.

B. Total number of participants stated in the protocol to be studied at all sites (regardless of PI).

40

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C. Maximum number of participants that are planned to be consented by this PI (including any anticipated withdrawals by participants, PI or sponsor OR consented screen failures).

40

Of the above, how many of these are expected to complete the study (participate in the study beyond screening?)

40

D. Check all that apply (*Complete and attach the appropriate supplemental form(s): NA

Children/minors* (Form #1117) Pregnant women/fetal tissue/placenta* (Form #1116)

X Cognitively impaired* (Form #1118) Prisoners* (Form #1115)

Comatose/Traumatized* (Form #1118) Students

Elderly/Aged – targeted Subordinates/Employees

Females of childbearing potential Terminally ill participants

Healthy Volunteers

Other, specify:      

VU Medical Students/trainees

E. Describe how the selection of participants is equitable in relation to the research purpose and setting (e.g., no one ethnic group is targeted or excluded, the same group of participants will benefit from the results of the research). Describe the composition of anticipated participants such as teachers, students, parents, etc.

Patients with mild traumatic brain injury

F. Does this study require registration with Clinicaltrials.gov? Please be aware there are four mandates that require registration of clinical trials and as the Principal Investigator for this study, it is your responsibility to assure proper registration of your trials. Failure to comply with applicable rules and guidance can result in serious penalties as well as restrictions on publications. In general, only some phase I clinical trials are exempt from registration. Click on the help buttons above for further information.

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X No If “No”, please provide a rationale of why registration is not required.

Yes If “Yes”, do you have the National Clinical Trials (NCT) Registry Number?

Yes, NCT Number:      

No, Submit the number through DISCOVR-E once received.

9. Does this study target one gender or specific social/ethnic group(s)?

X No Yes If “Yes”, please provide a rationale.

     

10. Is the population being enrolled in this study at high risk for incarceration?

X No Yes If “Yes,” will the participants be withdrawn from the study once they are incarcerated?

Yes No If “No,” describe how re-contacting/re-consenting,

treatment, and/or follow-up will occur.      

11. Use of Drugs, Devices, Biologics, and Gene Transfer X NA

A. FDA-approved Drug(s)/Biologic(s) Used for Research

i. Identify the name of all of the FDA-approved drug(s)/biologic(s) listed in this protocol along with a description of the dose range, frequency, the population it is used in, route of administration and source.

     

ii. Are any of these FDA-approved drug(s)/biologic(s) under investigation for a new indication*?

No, all drug(s)/biologic(s) are being administered within the FDA approved indication, route of

administration, dosage/frequency, population (e.g., children), etc.

Yes. If “yes,” please answer the following questions:

a. Are you intending to report the study results to the FDA to support a new labeling indication or labeling change?

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Yes No

b. Are you intending to report the study results to the FDA to support a change in the advertising?

Yes No

c. Does the planned use of the study drug increase the risks or decrease the acceptability of the risks to the subjects participating in the study?

Yes No

d. Does the study require any change in the approved formulation, dosage level, or route of administration of the drug?

Yes No

NOTE: If the responses to a-d above were all “NO,” the clinical investigation of the marketed drug or biologic may be considered IND Exempt. If not IND exempt, a written determination from the FDA is required. In

addition, the investigator must complete section B of this application.

iv. Describe how the drug(s) will be handled, stored, and dispensed.

     

B. Investigational (Non-FDA approved) Drug(s)/Biologic(s) used for Research

NOTE: Investigator-sponsors who will hold the IND for the study drug(s) must complete and submit the Supplemental Form for Investigator Held IND(s), IRB Form # 1135.

i. Identify the name of all of the Investigational Drug(s)/Biologic(s) listed in the protocol along with a description of dose range, frequency, route of administration and source.

     

ii. IND number assigned by FDA (Copies of all completed 1572s as well as documentation of FDA approval for the use

of the agent(s) must be provided for IRB review).      

iii. Who holds the IND? Sponsor

PI Complete the Supplemental Form for Investigator Held IND(s) # 1135

Cross-referencing another IND Complete the Supplemental Form for Investigator Held IND(s) #1135 and Include

the “Letter of Authorization” to Cross-Reference

iv. Are other research studies using this IND? No

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Yes If “Yes”, please list IRB #(s):

v. Will the Investigational Pharmacy be dispensing the drug(s)/biologic(s)? No

Yes

a. Identify the name of the Manufacturer or source of investigational drug(s)/biologic(s).     

b. If the source is not a FDA licensed facility, provide details regarding the purity, quality, stability and sterility of the investigational drug(s)/biologic(s).

     

c. Identify who will be preparing the investigational drug(s)/biologic(s), their qualifications, and describe how it will be prepared in detail. Note: If the drug(s) will be compounded by the Investigational Drug Service (IDS), attach the approved compounding formula. For more information, call the IDS at 343-6537.

     

d. Describe how the investigational drug(s)/biologic(s), will be handled, stored, and dispensed. Note: If the drug(s) will be handled, stored, and dispensed by the Investigational Drug Service (IDS) simply state “Contracted with VU Investigational Drug Service (IDS) for this service.”     

C. Device Use. (If a device is being used for research please complete the Supplemental Form for Use of Devices in Research, IRB Form#1134, for submission with this application.)

D. Gene Transfer (Note: If any answer in this section is checked yes, approval from the Institutional Biosafety Committee is required.)

i. Does this study involve the deliberate Transfer of Recombinant DNA, RNA, or DNA or RNA derived from Recombinant DNA into one or more human subjects?X No Yes

ii. Does this study utilize Live, Recombinant, and/or Attenuated Microorganisms for Vaccination of one or more human participants? X No Yes

iii. Does this study utilize a Select Agent as defined by the CDC in 42 CFR 72 (see page 14)?X No Yes

12. Does this study include any radiation ionizing procedure(s) for research?

X No

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Yes If “Yes”, please list:     

Note: Also, attach the appropriate HSRC/RDRC document(s).

13. Minimizing Risks to Participants/Data and Safety Monitoring Plan (DSMP)NOTE: If VU PI is accepting coordinating center responsibilities, address that specific role in each question below.

A. Describe how the risks to participants are minimized (e.g., screening to assure appropriate selection of participants, identify standard of care procedures, sound research design, safety monitoring and reporting).

They will all participate in a specific location with our watch.

B. Describe how the risks to participants are reasonable in relation to anticipated benefits (e.g., includes benefits to the individual as well as to human kind, indicate how the risks are justified in this population).

No known harmful risks exist in this study.

C. Is there a data safety monitor or board/committee to review this study for safety and adherence to the study protocol? NOTE: Regardless of the response to this question, all subsequent questions in this section must be addressed.X No

Yes If “Yes,” describe the composition of the committee and their qualifications.     

D. Provide a general description of the data and safety monitoring plan.They can withdraw from the study anytime they want.

E. Describe plans for monitoring the progress of trials and the safety of participants (e.g., timing of DSM reviews and reports, planned interim analysis, etc.). Note: DSMB reports are required to be submitted to the IRB at the time of continuing review unless the

information affects the risk/ benefit profile of the study.

We will be watching them while they complete the study.

F. Describe plans for assuring compliance with requirements regarding the reporting of adverse events (AEs), including plans for reporting of AEs to the IRB and appropriate regulatory agencies.

We will exclude their results if they don’t comply with the requirements.

G. Describe plans for assuring that any action resulting in a temporary or permanent suspension of a federally funded research project is reported to the grant program director responsible for the grant.

     

H. Describe plans for assuring data accuracy and protocol compliance.We will be watching them. They will all be doing similar tasks. Pre- and post examinations will occur.

14. How will non-English speaking participants be consented? X *Not Applicable at this time(Federal regulations require the equitable selection of minorities as research subjects to assure that they receive an equal share of the benefits of research and to ensure that they do not bear a disproportionate burden.)

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A. Choose one: A translated written informed consent document in a language understandable to the

participant. This should be an accurate translation of the full informed consent document (consider having a translator present during the consenting process should the participant have any questions).

Orally, using a qualified translator to translate the English informed consent document to the participant, and a translated short form in a language understandable to the participant. (See “Documentation of Informed Consent” at IRB Policy IV.B for details).

*Note: It is acceptable to submit the English informed consent document and the English short form, if there is no current non-English speaking person identified for the study. Once identified, the translated informed consent document or the short form must be submitted to the IRB for expedited review and approval prior to consenting the participant.

B. Identify the name of the individual or translation service that provided the translation.      

C. List the qualifications of the individual that provided the translation.     

15. Will a waiver or alteration of the consent process or a waiver or alteration of the consent documentation be used?

X No

Yes If “Yes,” please complete the Request for Waiver of Consent and/or Authorization

Please refer to IRB Policy IV.C for further guidance. Please be aware, if a protocol is granted a “Waiver of Consent and/or Authorization” by the VU IRB, and the study involves the use of PHI, the PI is responsible for accounting of disclosures. Please contact the Vanderbilt Privacy Office at: http://www.mc.vanderbilt.edu/root/vumc.php?site=HIPAA, or call 936-3594.

16. Will surrogate consent be requested?

X No

Yes If “Yes”, indicate rationale for use of surrogate consent.

     

17. Participant Identification, Inclusion/Exclusion Criteria, and RecruitmentA. Describe the specific steps to be used to identify and/or contact prospective participants. (If

applicable, also describe how you have access to lists of potential participants. Scripts and advertisements should be submitted with this application or examples should be provided for any telephone contacts, advertisements, oral contact, etc.)

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TBI Patients currently receiving treatment at the VA.

B. Describe the specific steps for obtaining informed consent (e.g., by whom, his/her credentials, where, when, etc.)

Before participating in the experiment, we will ask them to sign a consent form.

C. Does the person obtaining consent have an existing relationship with the participant(s)?

X No

Yes If “Yes”, indicate describe the relationship(s) and how you will protect against undue influence or coercion.

D. Identify the criteria for inclusion and exclusion and explain the procedures that will be used to determine eligibility. If psychiatric/psychological assessments will be conducted (e.g., depression or suicidal ideation screenings), state who will administer, his/her experience, and how risks will be managed.

Ages 21-40, participated in a war or served in the military, currently have a traumatic brain injury, want to find a rehabilitation tool that will minimize the symptoms of TBI

E. Please identify ALL applicable recruitment methods: NOTE: Please provide an approved copy of all advertising materials including ads, letters, and telephone scripts with this application (must include graphics). In addition, the IRB must review and approve final copies of all audio and videotapes prior to use.

X Not Applicable; or

Choose all that apply:

F. Do

you agree to release study information to Vanderbilt-approved list services, web sites or publications? (Vanderbilt has a variety of list services and publications, such as the Clinical Trials Website. Posting research protocol information on research-related websites and other listing services, allows potential participants to search and find studies

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Flyers Mass E-mail Sollicitation Radio

Internet Newspaper Telephone

Letter

Departmental Research Boards

Other (describe):      

Posters

ResearchMatch (IRB 090207)

Television

Social Media

related to their condition or interest. (Please be aware that if this research is subject to a contractual agreement, it may be necessary for you to obtain permission from the sponsor prior to authorizing the release of any study information.)

X No, do not release information to research-related web sites and other listing services.

Yes, this information may be released as described in item 1 of the informed consent document (Purpose of the study).

G. Will Protected Health Information (PHI) be accessed (used) in the course of screening/recruiting for this research?

X No

Yes If “Yes”, the following 3 conditions must be met:

1. The use or disclosure of the PHI is sought solely for the purpose of this research protocol.2. The PHI will not be removed from the covered entity. Note: See “The Statement of Hybrid Designation” for the definition of the Covered Entity.3. The PHI is necessary for the purpose of this research study.

18. Methods and Procedures Applied to Human Participants (check all that apply)

A. Have you attached a research protocol that includes a description of the following: background, rationale and specific aims, inclusion/exclusion criteria, enrollment/randomization, study procedures, adverse event reporting, study withdrawal/discontinuation, statistical considerations, privacy/confidentiality issues, follow-up, and record retention?

No If “No,” please complete and attach a research protocol that addresses the above criteria, as applicable.

X Yes

B. Placebo-controlled (inactive substances and/or sham products and/or procedures)

If an “inactive substance” will be used in the study, identify the name of the inactive ingredient along with a description of the dose range, frequency, route of administration and source.

     

1. Identify who will be preparing/providing the placebo.

     

2. Provide the details regarding the purity, quality, stability and sterility of the placebo and/or inactive ingredients.

     

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If a sham product and/procedure will be used in this study please describe:      

C. X Behavioral Observation

Describe the focus, duration, and number of observations and specify how the observations will be recorded.

We will have a sheet recording the time it takes to complete the study, number of mistakes based on accuracy and number of mistakes in sequencing.

D. X Randomization

     

E. Blinding

Describe who will be blinded. Describe if and when research results or previously blinded treatment assignments will be made available to participants. Describe the provisions for breaking the blind (e.g., emergency situations, participant’s request, etc.).

F. Investigational MethodsDescribe any methods that are being investigated (i.e. new surgical procedure, novel technique, a change in timing of interventions, change in processes).

G. X Surveys, Interviews, Questionnaires

If surveys, interviews or questionnaires will be conducted with this study, indicate who will conduct the survey, interview or questionnaire and their qualifications. In addition, describe the setting and mode of administering the instrument (e.g., by telephone, one-on-one, group, etc.) and attach a copy of the instrument.

We will have a post-evaluation survey to determine what needs to be improved on the prototype. We also want to know the concerns they have in participating in a rehabilitation tool like this.

H. X Document and Artifact Collection

Describe any documents or other artifacts (e.g., student written assignments, EKG report, x-rays, etc.) that are to be collected.

Post-evaluation survey

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I. Specimen Collection

i. Blood drawing (indicate total amount drawn for research purposes).

     ml over       period.Note: Please include description in consent document referencing amounts of blood in teaspoons, tablespoons or pints.

ii. Other specimens (describe the type of specimen and frequency of collection).

     

iii. Will specimens be obtained for genetic testing in association with this study or stored for future use? X No

Yes If “Yes”, include genetic template language in the informed consent document.

J. Deception, Withholding or Postponing Medications/Treatments, or Imposing other Restrictions

Describe the methods of deception to be used, the medications being withheld or postponed, the length of time medications will be withheld or postponed, any other restrictions to be imposed on participants (i.e., diet, exercise), and the precautions taken to decrease or eliminate risks to participants.

K. Data Collection, Storage of Data/Specimens and/or Issues of Confidentiality

NOTE: Any device (e.g., personal computer, laptop, etc.) used to save or store individually identifiable health information must be either encrypted or saved on a server housed in an approved data center. Vanderbilt Medical Center has agreed to use Check Point. For more information and how to obtain Check Point please visit the website: Information Privacy and Security.i. Describe the procedures that will be utilized to protect the privacy of the research

participant (where consent will be obtained, etc.). Indicate who will have access to the research information (for example, video/audiotapes, discovering information about the participant that could be harmful if released such as mental illness, genetic information, sexual preference, drug abuse, etc.).

We will keep all results on laptop locked inside the biomedical engineering department. A duplicate copy will be on a harddrive kept on the same place.

ii. Describe how the confidentiality of participants’ data will be assured. Include a description of any issues specific to the study that might increase the risk of breach of confidentiality. Describe how codes will be generated if codes are used to protect identities, and who will

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have access to such codes. If a certificate of confidentiality will be provided, include the name of the person holding the certificate. Describe the final disposition of research data when the study is concluded (e.g., will information be destroyed, will the PI maintain the information, etc.).

Subjects will be given a subject number from 1-40. No names will be recorded.

L. Audio or Video Taping

i. Describe how the audio/videotapes will be stored.     

ii. Describe how the tapes will be disposed of when this research is complete.     

iii. Describe how the participant’s confidentiality will be maintained.     

M. Use or Disclosure of Protected Health Information

Does this research use or disclose Protected Health Information (PHI)?Protected health information (PHI) is individually identifiable health information that is or has been collected or maintained by Vanderbilt’s Covered Entity, including information that is collected for research purposes only, and can be linked back to the individual participant.

X No

Yes If “Yes”, please continue:

i. Indicate the source of the PHI to be collected (e.g., medical records, specimens, data previously collected for research purposes).

     

ii. Indicate when PHI will no longer be accessed (e.g., closure of study, destruction of database, no expiration).

     

Identify all Non-VU affiliated Individuals/Institutions (those that are outside the covered entity) to which PHI may be disclosed (e.g., study sponsors, CRO’s, consulting physicians, publications, future collaborators, etc.):

Name of Institution and/or Individual Data Use Agreement Required?

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Yes No

Yes No

Yes No

Yes No

19. Potential Conflict of Interest

A. Is there a potential conflict of interest for the Principal Investigator or key research personnel?Assessment should include anyone listed as Principal Investigator, or other research personnel on page 1 of this application. Please note that the thresholds of ownership described below apply to the aggregate ownership of an individual investigator, his/her spouse, domestic partner and dependent children (e.g., if an investigator, his/her spouse, domestic partner and dependent children own together $10,000 or 5% worth of equities in the sponsor, it should be reported below). Do not consider the combined ownership of all investigators.

X No

Yes If “Yes”, the investigator must complete and submit IRB Form #1120, “Conflict of Interest Supplemental Form” with this application. Form #1120 and the protocol must be reviewed by the VU Conflict of Interest Committee.

NOTE: Although approval may be granted by the IRB, the Investigator may not proceed with the research until a final determination letter has been rendered by the MCCOIC or the University Conflicts Committee.

B. If “Yes”, check all that apply:

Compensation whose value could be affected by the study outcome.

A proprietary interest in the tested product included but not limited to, a patent, trademark, copyright or licensing agreement, or the right to receive royalties from product commercialization.

Any equity interest in the sponsor or product whose value cannot be readily determined through preference to public prices (e.g., ownership interest or stock options).

Any equity interest in the sponsor or product that exceeds $10,000 or 5%.

Significant payments or other sorts with a cumulative value of $10,000 made directly by the sponsor to any of the investigators listed on page 1 of this application as an unrestricted research or educational grant, equipment, consultation or honoraria.

Informed Consent Document Templates

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Download from http://www.mc.vanderbilt.edu/irb/forms/ then save and submit as a separate file from the IRB Application.

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Volunteer Consent Form:

Please read the following text carefully before participating in our beta study.

Traumatic Brain Injury background information

The Defense Department estimates that approximately 20% of soldiers have suffered TBI. [1]According to the CDC, 1.4 million Americans experience TBI each year, 50,000 of which die. The CDC also reports that an estimated 5.3 million Americans live with disabilities caused by TBI. Disabilities due to TBI causes lost of productivity and life. TBI damage ranges from mild to severe and from attention deficit to memory loss.

Project Objective

The purpose of our project is to help TBI patients regain competence in the job market by guiding them to regain executive skills. We plan to improve their memory by doing specific tasks. We will have a virtual video showing the steps which can be modified to suit the individual’s needs. We will then have a model of the video where the patient can implement the learned task.

Our tool can also be used for neuro-rehabilitation evaluation. It can evaluate the extent of TBI injury depending on the patient’s performance on the task.

Beta Study

You will be tasked to watch a video on making a burger or setting up a table. An instruction screen will show up which will let you determine the difficulty level you want the video to be shown. The difficulty will determine the rate the which the video will be presented. After the video, you will be tasked to complete the task using the model provided. You will be evaluated by your performance on the task.

Are there any benefits, costs or risks of volunteering for the study?As a beta test volunteer, you are involved with research that might help improve the rehabilitation process for traumatic brain injury patients.

There are no personal benefits or costs associated to you on this beta testing. No financial compensation will be provided.

AGREEMENTBy agreeing to participate on this beta test, you consent to follow the procedure and allowed the results of your beta test to be used for our prototype analysis. You assure that you will try your best to achieve the best results for the test. You are also required to answer a post-evaluation survey to help improve our prototype.

Name:_______________________

Signature:____________________ Date:_____________________

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Post-evaluation survey:

TBI Rehabilitation Tool Survey

David Weinberg1, Erwin Yap1, Dr. Joseph Cheng, MD.2

1Vanderbilt University, Department of BME, Nashville, TN

2Vanderbilt University Medical Center, Nashville, TN

TBI background information

The Defense Department estimates that approximately 20% of soldiers have suffered TBI. [1]According to the CDC, 1.4 million Americans experience TBI each year, 50,000 of which die. The CDC also reports that an estimated 5.3 million Americans live with disabilities caused by TBI. Disabilities due to TBI causes lost of productivity and life. TBI damage ranges from mild to severe and from attention deficit to memory loss.

Project Objective

The purpose of our project is to help TBI patients regain competence in the job market by guiding them to regain executive skills. We plan to improve their memory by doing specific tasks. We will have a virtual video showing the steps which can be modified to suit the individual’s needs. We will then have a model of the video where the patient can implement the learned task.

Our tool can also be used for neuro-rehabilitation evaluation. It can evaluate the extent of TBI injury depending on the patient’s performance on the task.

Common symptoms of Mild Traumatic Brain Injury:

1. Speech problems2. Weaken comprehension3. Decreased short term memory 4. Attention deficit 5. Sequencing problems

In light of the background information provided, please rate our prototype on a scale of 1-10 regarding the following criteria:

1(goal failed) to 10 (goal very successful);

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1. Easy to learn how to use? ________

2. Is engaging for the user and maintains user’s attention? ________

3. Is simple to navigate? ______

4. Accurately demonstrates that task that must be completed? ________

5. Instructions are easy to follow? _________

6. Video quality is good? _________

7. Images are realistic? _________

8. Difficulty levels are appropriate? __________

9. Has excellent potential for use as a neuro-rehabilitation tool? ________

10. Is applicable as an instructional tool for to non-TBI users such as people looking for jobs (like someone making a burger at Mcdonalds)________

Additional comments

_______________________________________________________________________________________________________________________________________________________________________________________________________________

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Session 2 of COGsmart program conducted by VA:

Session 2 — Managing Fatigue, Sleep Problems, and Headaches

Goals of Session:

1. Review homework2. Discuss TBI-related fatigue, sleep difficulties, and headaches, and provide

recommendations for coping with these problems3. Introduce general tension reduction techniques4. Practice progressive muscle relaxation5. Assess use of calendars/organizational devices

1. Homework review

Assess homework completion. Discuss experiences implementing strategies. Troubleshoot any barriers.

2. Managing specific symptoms: fatigue, sleep problems, and headaches

These are some of the most common and distressing symptoms experienced after TBI

Often related to cognitive and emotional concernsFatigue

May tire more easily and have more difficulty rebounding from busy days Fatigue can intensify other TBI-related symptoms

o Examples? Reducing fatigue

o Exert yourself when you’re most energetico Recognize your limitso Build in downtime, take breaks

What can you do during work breaks?__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Sleep Problems

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DOWNTIME:

1 HOUR PER DAY

1 DAY PER WEEK

1 WEEK EVERY 12-16 WEEKS

Sleeping pills and alcohol do not work well in the long run and do not teach your body how to sleep better. They also can be addictive.

Implement healthy sleep habits 1. Avoid activities other than sleeping, such as reading, working, lengthy

conversations, or watching TV, in bed2. Go to bed only when you feel sleepy—this will eventually establish a sleep

routine for you3. If you don’t fall asleep within 20 minutes, get out of bed and sit quietly in the

dark. Avoid switching on any overhead lights. Avoid looking at the clock4. Try to go to bed at roughly the same time each night5. Wake up at the same time each day, and get out of bed as soon as you wake

up6. Try not to nap longer than 30 minutes (best to avoid naps all together)7. Avoid exercise, excessive physical activity, or other excitement about 4 hours

before you go to bed8. Create a sleeping environment that is most comfortable for you9. Reduce outside noise (e.g., earplugs, “white noise” machine)10. Avoid caffeine after noon, and tobacco and alcohol at least 2 hours before

you go to bed11. Develop “bedtime rituals” (e.g., eating or drinking particular foods, taking a

warm shower) before going to bed Individuals with combat-related head injuries commonly experience post-

traumatic stress symptoms that can impair sleep, such as nightmares and increased arousal. Let us know if these are concerns for you and we can discuss potential treatment options.

Headaches

Tension headaches are most common type of “posttraumatic headache”o Band of pressure around heado Neck or jaw discomforto Tenderness on your scalp, neck, and shoulder muscleso Difficulty sleeping o Fatigueo Irritabilityo Loss of appetiteo Difficulty concentrating

If you are frequently bothered by headaches, it may be appropriate to consult with a physician (e.g., to discuss medications)

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SLEEP DISTURBANCE FATIGUE COGNITIVE DIFFICULTIES

Triggers/aggravating factors (minimize these if possible)o Stresso Depression and anxietyo Lack of sleep or changes in sleep routineo Skipping mealso Poor postureo Working in awkward positions or holding one position for a long timeo Medications used for other conditions, such as depression or high blood

pressureo Overuse of headache medicationo Jaw clenching and teeth grindingo Lack of physical activity

Physical activity reduces tension, fatigue, and stress and improves sleep

Which three strategies would you like to try first to help address fatigue, sleep problems, and/or headaches?

(1)__________________________________________________________________

(2)__________________________________________________________________

(3)__________________________________________________________________

3. Tension reduction techniques

Tension reduction techniques break this cycle by decreasing tension and anxiety

Abdominal Breathing = breathing from the depths of your abdomen

Inhale through your nose, slowly, until the breath reaches your abdomen, to a count of 5

Release, exhaling from your nose or mouth to a count of 10 You can place your hand on your stomach, and if you’re doing this correctly, your

hand will actually rise and fall with each breath Try to concentrate on your breathing, and clear your mind of anything else if you

can Keep this up for 3-5 minutes, and do it as often as you can throughout the day,

and in bed, before you go to sleep

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TENSION ANXIETY COGNITIVE DIFFICULTIES

Grounding Techniques = directing attention to something in your environment

Find a quiet room where you can be alone Observe and describe objects in the room, by their physical properties Do not attach your opinions to the objects You can also incorporate abdominal breathing

Visualization = mental relaxation that generates a peaceful state of being

Imagine that you are in a different, peaceful place Enrich the visualization by imagining accompanying sensations (sights, smells,

sounds, textures, temperatures) The visualization process consists of 3 steps:

o Preliminary relaxation (abdominal breathing for about 5 minutes)o The visualization exercise (two examples of scripts are provided below)o Returning to an alert state of mind

Can be done along with PMR or alone See example scenarios below

Walking in the Forest (adapted from The Mild Traumatic Brain Injury Workbook by D.J. Mason, Psy.D.)

You’re walking along a path deep in the forest, surrounded by tall trees… pine, fir, redwood, oak…look up and try to see them. The cool, crisp breeze blowing gently through the leaves of the trees is so soothing, and whispers to you to clear your mind… let go of all your thoughts and worries. You take a deep breath to take in the rich dampness of the forest floor, the smell of earth and the leaves, little wildflowers, and new seedlings. You sit for a moment on a broad, flat stone and look up at the trees. You can see the gorgeous blue sky, with little wisps of white clouds through the treetops. You can see how the sun filters through the canopy of treetops and splinters into rays that gently hit the forest floor. The patterns of light and shadow make the forest feel like a great, primeval cathedral… filling every sense of your being with incredible peacefulness. You also feel reverence for all living things… the trees, grass and flowers, the little forest creatures that you can hear scuttling around the forest floor and trees. As you walk further into the forest, you are beginning to pick up the distant gurgling of moving water. It gets more and more distinct as you keep walking, and you suddenly come upon a shallow stream, which sits at the edge of a bright, grassy glade. You look into the pristine, sparkling water, and see the shiny, black pebbles that dot it here and there. You sit down on a rock, take off your shoes and socks, and place your feet in the cold water. Your tired feet are instantly soothed, and you bend over, and see your own, serene face in the water. After a while, you get up, and walk across the narrow width of the stream and on to the grass. You are surprised at how velvety the grass feels between your toes. You walk right into the middle of the glade, and decide to lie down on the grass. You can feel your body getting very loose… your shoulders fall back and relax, and you can feel the gentle sunshine nudge against your closed eyelids. You slowly open your eyes, and see the sky again… this time, it stretches out as far as the eye can

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see… unfettered by treetops. You are aware of the stream pleasantly singing in the background, and you see the clouds again, this time slowly drifting by. You see a bald eagle gently gliding across the sky, looking for a meal for her hungry family, or perhaps taking in the beautiful surroundings, just as you are. You are content here… the sights, sounds, and smells of this beautiful forest have filled you with a deep sense of peace.

Sunlight Meditation (from The Anxiety and Phobia Workbook [Third Edition] by E.J. Bourne, Ph.D.)

You are in a calm, beautiful place outdoors… perhaps the beach, a park bench, a boat in the middle of the ocean, or parasailing across the wide-open sky. Now imagine that you feel a warm, gentle breeze blowing over your body. You can see the beautiful blue sky and some clouds that look like fluffs of cotton. Shining directly overhead is the sun.

Now imagine that you can feel the warmth and light from the sun wash over you…you feel it beginning to relax and soothe every part of your body. In a moment, you might concentrate on this sunlight and move it over to your right arm. Focus it there. Just feel the warmth and light from the sun penetrating the fingertips of your right hand. You can feel it soothing and relaxing your right hand. And in a moment it begins to move from your right hand to your forearm… and then, to your upper arm… and then to your shoulder. Just feel the sunlight warming and soothing your entire right arm. You can feel it filling and soothing every muscle, tendon, and nerve in your right arm. And you feel your right arm – from the tips of your fingers to your shoulders – becoming completely relaxed. And you find yourself letting go more and more… becoming more and more at peace.

Now move the light from the sun to your left arm. Imagine it entering and soothing your left hand. And in a moment you can begin to feel it moving from your left hand up your left arm… soothing your forearm… and then your upper arm… moving all the way up to your shoulder. You’re relaxing all the muscles, nerves, and tendons in your left arm… feeling the light penetrating and soothing your entire left arm. Just continue to let yourself drift deeper and deeper into quietness and peace… feeling very safe, secure, and relaxed.

And gently, now, take the light from the sun and move it over to your right leg. Allow it to move from the tips of your toes all the way up your right leg to the hip joint. Feel the warmth as the sunlight moves through your right leg, from your right foot to your right calf… and then to your right knee… and then to your right thigh… and finally to your right hip bone. Just feel the sunlight penetrating and soothing every muscle, tendon, and nerve in your right leg and hip. Your entire right leg is feeling completely relaxed.

And in a moment, feel the sunlight move to your left leg. Again, allow it to move from your left foot up through your entire left leg to your hipbone. Feel it soothing and relaxing your left ankle… then your calf… and then your knee… and then soothing all the muscles in your thigh… and finally moving up into your hip. You can feel the sunlight penetrating every muscle, tendon, and nerve in your entire left leg. And in a moment you find your left leg feeling completely relaxed.

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And now move the light from the sun into your stomach area. Just feel it warming and soothing every organ in the lower part of your body. Just feel the pressures and tensions of the day draining away from you… as your stomach and lower abdomen relax completely. Feel your stomach and lower abdomen becoming very relaxed.

Now take the light from the sun and move it to your chest area. Let it soothe and comfort that area. Just feel it streaming into your chest. You are feeling relaxation… peace… and comfort throughout your entire chest… feeling your chest becoming very relaxed and your breathing becoming easy.

Now, in a moment, you might bring the light from the sun down through the top of your head. Imagine it soothing and comforting the top of your head… and then the area around your eyes … and then your jaw. And in a moment, feel the warm, soothing sensations of the sunlight moving down into your neck, relaxing and releasing every tight muscle in your neck. And in a while you can feel your neck completely relaxing. Your head and neck are becoming completely relaxed.

And now let the sunlight move down your spine, down through your spine all the way to your tailbone… let it move down through your entire spine. And then imagine the light moving out from your spine into every nerve of your body. Feel the sunlight moving into every nerve of your body, healing and relaxing all those nerves. And as all of your nerves relax, you can enter into a very deep state of peace.

Just allow yourself to drift deeper and deeper into quietness and peace… becoming more and more relaxed. In a moment you can feel the sunlight relaxing and soothing every single cell in your body. Every single cell in your body is becoming very relaxed. And you feel yourself becoming very deeply relaxed… very much at peace.

Coming Out of a Visualization

Count from one up to five. At five, you can open your eyes and feel awake, alert, and refreshed.

One… gradually start becoming aware of your present surroundings Two… wiggle your toes and stretch your legs Three… wiggle your fingers and stretch your arms over your head Four… Exhale Five… Open your eyes, finding yourself fully awake, alert, and refreshed

Progressive Muscle Relaxation (see description from last week)

4. Activity: PMR practice

What did you notice this time about doing PMR?

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5. Assess use of calendars/organizational devices

Did you know that the VA can provide PDAs (personal digital assistants, like Palm Pilots) to veterans who have had head injuries? Just let us know if you are interested in receiving a PDA. They will even teach you how to use it.

If you would prefer a paper calendar, we have several different types available for you to choose.

HOMEWORK SHEET

Instructions: Homework assignments are designed to encourage class members to practice the skills they are currently learning in the cognitive training class. The class leaders will give a specific assignment each week, which will be written on this form. The class leaders will review the completed homework sheets the following week.

Client: Date Assigned:

Assignment:

Practice PMR 2 times over the next week.

Choose 3 additional tension reduction techniques to practice.

This skill is important for me because it will help with:

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Date practiced: Time: Location:

Briefly describe what took place:

How did it go?

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