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SPOTLIGHT ON PARKINSON’S DISEASE: THE ABC’S OF DBS
PARKINSON’S DISEASE
TUESDAY JUNE 26, 2018
WELCOME AND INTRODUCTIONS
Stephanie PaulVice President Development and MarketingAmerican Parkinson Disease Association
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PRESENTATION
Jill L. Ostrem, MDCarlin & Ellen Wiegner Endowed Professor of Neurology
Division Chief, UCSF Movement Disorder and Neuromodulation CenterWeill Institute of Neurosciences
University of California San Francisco
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Salary & Grant Support: Educational- Medtronic, Allergan, Boston Scientific AbbVie; Clinical Trials- St Jude Medical, Boston Scientific, Google, Cala Health, Medtronic
Honoraria: None
Speaker’s Bureau: None
Equity & Consulting Agreements: AbbVie, Adamas, Neurocrine, Medtronic
FINANCIAL DISCLOSURES
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• What is DBS?• Who is a candidate?• What is new in DBS for PD?
OUTLINE
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WHAT IS DEEP BRAIN STIMULATION?
• Surgical procedure used to treat a variety of neurological symptoms
• Does not damage the brain, instead influences electrical signals in brain circuits
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DBS LEAD ELECTRODE SELECTION AND STIMULATION PARAMETERS
* The negative electrode exerts the therapeutic effect
Unipolar
0123 off
off
(-)
off
(+) positive
Rate(Hertz)number of pulses per second
Pulse Width(µsec)duration of each stimulus
Amplitudeintensity of stimulation
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• The motor system is composed of interconnected loops• Motor cortex to basal ganglia to thalamus to cortex • System initiates and maintains desired movements while filtering out
undesired movements • In PD, loss of dopamine disrupts communication through these loops• DBS thought to break up the pathological signals
HOW DOES DBS WORK?
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Most Candidates:• Moderate/advanced PD disease• Levodopa-responsive• Experiencing motor fluctuations• Experiencing dyskinesia• “Failed” good control with medical
treatments
WHO IS A CANDIDATE FOR DBS?
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Minority:• Overall milder disease, but:
• Severe rest tremor resistant to levodopa
• Painful off-medication state dystonia• Severe dyskinesia with low doses
levodopa• Disability preventing employment
WHO IS A CANDIDATE FOR DBS?
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• Significant psychiatric illness• Psychosis• Depression
• Cognitive Impairment• Significant medical co-morbidities• Unrealistic goals and expectations
WHO ARE NOT GOOD DBS CANDIDATES?
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• Optimization of medications • Detailed motor testing (on and off
medications)• Neuropsychological testing• Psychiatric evaluation (in some cases)• Pre-operative Brain MRI
PARKINSON’S DISEASE CANDIDACY FOR DBS
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PARKINSONIAN SYMPTOMS AND DBS
Predictors of Good Response Not DBS ResponsiveIdiopathic PD Atypical or Parkinson Plus
SyndromesLD responsive, good ON function LD unresponsiveSymptoms not adequately controlled• Dyskinesia or motor fluctuations• Medication refractory tremor• Frequent or severe OFF periods• Off period disability from:
• Bradykinesia• Rigidity• Tremor• Dystonia
Severe disability during best ON time• Balance and gait impairment• Freezing of gait• Dementia• Depression or psychosis• Older Age?
Most non-motor symptoms
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Identify your patient specific PD symptoms you hope DBS will improve:
REALISTIC EXPECTATIONS FROM DBS
• Tremor• Slow movement • Stiffness• Dyskinesia• Falls/balance• Painful dystonia• Depression/Anxiety• Hallucinations
• Poor Speech• Poor Sleep• Freezing• Unexpected Off time• Medication side effects• Poor dexterity• Motor fluctuations
Are these symptoms DBS responsive?How levodopa responsive are these symptoms?Is tremor and/or dyskinesia in the top 3?
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CUSTOMIZED DBS FOR PD
Which device / Which lead? One or both sides?
Which surgical method?
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STN VS. GPI
Both targets - similar in improving motor symptoms and quality of life in PD
STN GPi
More commonly used target Easier for programming
More medication reduction Possibly less cognitive impact long term
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UPDATES IN DBS FOR PARKINSON’S DISEASE
• Updated indication for PD:• FDA approves DBS for earlier stage PD 2016 (>4 years
disease duration
• New DBS Manufacturers• Medtronic: Activa Series• Abbott: Infinity (US FDA approved 2016) • Boston Scientific: Vercise (US FDA approved 12/2017)
• New DBS surgical methods• Interventional MRI• Intra-operative CT
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Typical Progression and Clinical CourseTypical Progression and Clinical Course
Fahn. Ann NY Acad Sci. 2003;991:1-14.
0 3 8 15 20Years
OnsetDiagnosis
Therapy
Preclinical Phase
HoneymoonPeriod
Motor ComplicationPeriod
ResistantSymptoms
Cognitive Decline
-2 to -6
DBSTherapy ?
HOW EARLY SHOULD WE OFFER DBS FOR PD
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“DBS PD EARLY STIM TRIAL”
2 year long German trial; N= 251 PDEarly motor complications (mean disease duration 7.5 yr)Divided patients to DBS plus medication OR medication alonePrimary objective was measurement of quality of lifeDBS group improved quality of life scores by ~8 pointsBest medical therapy worsened by 0.2 pointsDBS superior in motor disability, activities of daily living, Sinemet-
related complications and on time.• DBS improves quality of life 19
Medtronic Activa System
NEW DBS SYSTEMS
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INFINITY™ ABBOTT/ ST JUDE MEDICAL DBS SYSTEM
• FDA approval 2016• Approved in Australia
and Europe• Constant current device• “Upgradeable” DBS
system- Bluetooth wireless
• Communicates with Apple digital devices
• Directional lead
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DIRECTIONAL LEAD
Intraoperative study, Pollo et al. found 43% less current needed for therapeutic benefit in directional lead
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VERCISE™ BOSTON SCIENTIFIC DBS SYSTEM
• FDA Approval 2017• Constant current device• 8 lead electrodes• Small rechargeable
battery• Fractional current delivery• MRI is not safe
Clinician Programmer
Charger
Remote Control
Charging Collar
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NEW SURGICAL METHODS
Traditional DBS Surgical Procedure
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• Developed at UCSF (ClearPoint system)
• Allows patients to be asleep during the procedure
• Surgical procedure is faster with fewer brain penetrations
Interventional MRI for DBS lead placement“Asleep DBS”
NEW SURGICAL METHODS
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Pros• Comparable efficacy• Accuracy Excellent• No MER
• Reduced brain penetrations
• No physiology expertise needed
• Patient asleep
INTERVENTIONAL MRI
Cons• Technique not readily
available• No intraoperative MRI• MRI suites used 24/7
• Reported outcomes limited to a few centers
• MRI visualization• GPI: Usually good• STN: not always great• VIM: not visible
• Bias of traditionalist: anatomically well placed leads can still be ineffective
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MRI SCANS IN DBS PATIENTS-MEDTRONIC SYSTEMS
• Previously only Head MRI’s were approved with SARs <0.1 W/kg (low frequency power limit)- DBS had to be turned “off”
• FDA approved Medtronic DBS systems for only full-body MRI Conditional Use. (Dec 9, 2015), new measurement
• DBS system can be left “on” now if in bipolar mode, can be done with any coil, 1.5T closed bore magnet.
• Fill out eligibility sheet- Medtronic help (1-800-707-0933), give to radiology staff
• Only applies if:• Activa portfolio DBS (Not Soletra, Kinetra, Active SC model
37602, and model 64001/2 pocket adaptors) – 2 prong connector/adaptor – beginning of 2009 – new systems will be all whole body eligible.
• No broken conductor (lead extension or pocket adaptor), standard IPG placement
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FUTURE ADAPTIVE DBS FOR PD
• Determine signals of parkinsonian state
• Signals that correlates with symptoms severity
• Signals that are modulated by medication/DBS
• New Medtronic IPG (Activa PC+S) allows for • Therapeutic stimulation • Recordings of brain activity
• STN/GPi using DBS lead
• An additional electrode (cortical or other)
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CLOSED-LOOP “ADAPTIVE” PARADIGM
Patient at homePAC
Frequency (Hz)
electrodesFreq
uenc
y (H
z)
PSD
coherence
elec
trod
es
Frequency (Hz)
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• Driven by high prevalence of neurological and psychiatric disorders, massive unmet medical needs in treatment options, robust R&D investments and technology developments
• Expanding DBS indications:
EXPANDING DBS INDICATIONS
• Epilepsy• Tourette’s Syndrome• Depression• Addiction • PTSD• Chronic Pain• Obesity
• Anorexia• Alzheimer’s Disease and Dementia• Tinnitus• Traumatic Brain Injury• Minimally Conscious State• Stroke Recovery• Headache
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UCSF MOVEMENT DISORDERS
NeurosurgeryPhilip Starr, MD, PhDPaul S. Larson, MDEdward F. Chang, MDDaniel Lim, MD, PhDKrzysztof Bankiewicz, MD, PhDCoralie De Hemptinne, PhDWhitney Chen, PhDDoris Wang, MD, PhD
NeuropsychologyCaroline Racine Belkoura, PhD
NursingMonica Volz, FNP, MSKaren Merchant, MSNSusan Heath, MS, RNGina Bringas-Cinco, RNAnnie Li Wong, NP
NeurologyJill Ostrem, MDNicholas Galifianakis, MDCaroline Tanner, MD, PhDMarta San Luciano, MDMaya Katz, MDIan Bledsoe, MD,MSJames Maas, MD, PHDChadwick Christine, MDMichael Aminoff, MDRobert Edwards, MDKen Nakamura, MD, PhDAlexandra Nelson, MD, PhDMichael Geschwind, MDAmy Viehoever, MD, PhDNijee Luthra, MD, PhDCameron Dietiker, MD
FellowsJessica Weinstein, MDKyle Mitchell, MDJennifer Choi, MDEthan Brown, MDMitra Afshari, MDMelissa Heiry, MDIdit Tamir, MD, PhD
Research /Support StaffSarah Wang, PhDKristen Dodenhoff, BAFarah KauserJoncarmen MergenthalerJanet AllenShatara BlackmonYasmeen GonzalezJeverly CalaunanKathleen Comyns, MPHSamantha Betheil, BACheryl Meng, MPH Danilo RomeroKanchi Mehta
PsychiatryAndrea Seritan, MD
Social WorkMonica Eisenhardt, LCSW
ChaplinJudith Long
Physical TherapyNancy Byl, PT, PhDHeather Bhide, PT
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QUESTION & ANSWER
Jill L. Ostrem, MDCarlin & Ellen Wiegner Endowed Professor of Neurology
Division Chief, UCSF Movement Disorder and Neuromodulation CenterWeill Institute of Neurosciences
University of California San Francisco
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CLOSING REMARKS
Stephanie PaulVice President Development and MarketingAmerican Parkinson Disease Association
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FOR ADDITIONAL INFORMATION, ANSWERS TO YOUR QUESTIONS, OR FOR ADDITIONAL RESOURCES
Please visit our websiteapdaparkinson.org
Or call us1-800-223-2732
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