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ST-NET Project

CE Certification

ST-NET and the STDM software has received theCE certification as medical device. The softwareincreases the efficacy and safety of ScramblerTherapy, and is therefore considered as anintegrating part for the correct usage of themedical device itself and its best clinical practice.For this reason the software certification is that ofa medical device.

Scrambler Therapy is a therapy that does not requiremedical device parameter setting, but its operator-dependent feature is of critical importance. This featureis based on correct methodology implementation andfull compliance to protocol guidelines.

In the beginning, when Scrambler Therapy's scientificinnovation was first introduced in the chronic pain area,a lot of attention from the scientific and medicalcommunity was focused on possible placebo effect intrying to explain results the seemed “incredible”. Thisselective focus together, with poor knowledge abouttheory principles and correct usage methodology,completely different from any other type of electro-analgesia, has determined a neglect of other variablesthat are statistically much more meaningful in theirimpact on treatment results than placebo. Morespecifically, in reference with official scientific literature,all double blind clinical trials on chronic neuropathic and

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oncologic pain in the advanced stage disease, clearlyshow that placebo effect is statistically relevant, but theextent is so mild to be substantially useless in painrelief.

In Scrambler Therapy, the relevance of operator-dependent variable and compliance to official treatmentprotocol guidelines has been undervalued for a longtime. Success- rate variables in these cases can reachand exceed 40%, an absolutely very high percentage,unacceptable in reliable clinical trials or routine clinicalpractice. After having formalized this concern to thescientific community (Inaccuracy in the article"Managing chronic pain: results from an open-labelstudy ......". Support Care Cancer. 2011Oct;19(10):1483-4. Epub 2011 Aug 2. PubMedPMID: 21808993.) all necessary solutions to minimizethis operator-dependent variables have been identifiedand can be summarized in:

- Official free standard training course on the correctusage method.

- An official freely accessible information source (thissite) on all needed information necessary to carry outunbiased clinical trials and verify guideline compliance.

- An always available telematics support for ScramblerTherapy users that provides tools to solve possibleissues (STDM).

ST-NET project is based on ST-NET, an international

automated network free for Scrambler Therapy users.This network has been set up for various purposes, butits main one is to support Clinical Trials and PilotCenters in reducing to a minimum operator dependentvariability results. By so doing, a quality system iscreated that regardless of clinical trials chosen byresearchers, guarantees reproducibility and consistentresults differently not achievable, therefore reliablescientific clinical trials.

ST-NET is focused on a clinical “intelligent” folderbased on a dedicated software designed exclusively forScrambler Therapy. Scrambler Therapy Data Manager,(STDM) software manages in a simple and effective

way patients medical records in an easy to use visualdatabase. During compilation, STDM automatically

informs the operator of possible critical features, andsuggests most fit treatment protocols for any patient

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and enables to use specific research tools such asBrief Pain Inventory, Pain Detect, DN4 and muchmore. This software can simultaneously (while you areworking on the record) open patient's data on othertraditional software such as Excel, Word or simplyNotepad. It is also possible to analyze treatment trendswith graphs that do not require previous configuration.The entire Database can be exported in standardformats with filtering criteria based on data, pain type orother meaningful characteristics in clinical trials.

By clicking on “Automatic analysis” an algorithmanalyzes the treatment data and highlights themain control parameters, indicating the percentageshift from the normal values.Meaningful shifts orserious anomalies are highlighted.

The softwareisautomaticallyconnected toST-NET.Whennecessary itsends in justa coupleseconds andlittle PC andnetwork commitment, completely anonymous 128 bitencrypted data. This data is collected in anInternational Hub, and becomes a shared referenceknowledge. Data collected in the International Hub isautomatically analyzed by an algorithm that detectspossible treatment mistakes. If in your country there is a

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local authorized training facility, you will quickly receivefree consultancy to solve possible criticality inmethodology implementation, non standard protocols,“complicated” patients, or other problem-solvingsupport. If there is no local support in your country, youcan receive help through Skype , or also email insolving minor issues.

Data sent over ST-NET network are renderedanonymous, and pertain exclusively to foldersmanaged by STDM. No other data type belongingto the system where the software is installed(including information rendered available by theoperating system) is analyzed or sent over thenetwork.

Health Insurance Portability AndAccountability Act (HIPPA) ComplianceST-NET is fully compliant to HIPAA privacy standards.Implemented multi-level protection requirements arehigher than those in most popular commercialsoftware.

Data protection for publications

Clinical trial data is intrinsically protected by being puttogether with all those of other countries in the sameDatabase, therefore coupled with anonymous patientdata, they loose their feature of main and exclusivesource. However, when you open a patient medicalrecord in STDM you can easily add the confidentialityfeature by ticking on a specific option. By so doing yourresearch data is automatically sent into a secondaryHub and frozen for the selected time span (0 to 5years), that can be extended just via email.

If you include ST-NET use in the protocol to be

approved by the Ethical Committee/IRB as a qualityand reproducible support system for clinical trialsunderway, you can establish within the protocol itselffurther constraints deemed necessary for dataprotection, together with approved monitoring onprotocol compliance to Scrambler Therapy guidelines.You will receive a formal acknowledgement on correctmethodology implementation in clinical trials, andoptimization on unbiased research that in some pastpublications has led to partially unreliable data. Theissue of unreliable data from general official guidelines

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that you can find in this website has been documentedby published scientific literature.

Currently, ST-NET and standard official training

represents the most updated methodology solution todevelop high quality reproducible clinical trials,generating methodology-reliable scientific data tocompensate for the operator-dependent variable.

ST-NET from its international activation, together with

primary international training courses for clinicalresearchers and trainers (held without cost by Prof.Giuseppe Marineo) in Italy or secondary trainingspecifically for Scrambler Therapy users, held in Italyand other countries by certified trainers, are the officialgolden standard acknowledged to be used as a qualityand reproducibility system in Scrambler Therapy clinicalresearch .

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