Kimberly Anderson-Erisman, PhD - United Spinal Resources

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Webinar title: Direct Nerve StimulationWhat is it really and what is the potential?Presenter/presenters:Kimberly Anderson-Erisman, PhDDirector of EducationUniversity of Miami & Miami Project to Cure ParalysisJennifer French, MBAExecutive DirectorNeurotech Network

Jennifer French, MBA

Kimberly Anderson-Erisman, PhD

Want to Ask a Question?

Disclaimer pageThe information presented in this webinar is not meant to replace the advicefrom a medical professional. You should consult a health care professionalfamiliar with your specific case, concerns and condition.Neurotech Network and its representatives do not endorse, rate, sell,distribute, prescribe, administer or recommend any products, proceduresor services. We highly suggest for you to take information to a trainedmedical professional familiar with your case to discuss options that arebest for you.

www.NeurotechNetwork.orgwww.themiamiproject.orgThe Miami Project is dedicated tofinding more effective treatmentsand, ultimately, a cure for paralysisresulting from spinal cord injury.Helping people regain life thruneurotechnologyFocusing on education of andadvocacy to access neurotechnologydevices, therapies and treatments forpeople living with impairments, theircare-givers and medical professionals.

Objectives Understanding the Human Nervous System Introduce various purposes of stimulation toa nerve Differentiate implanted from externalstimulation Technology applications Peripheral Brain Spinal Cord Resources to learn more

The Human Nervous System

The Human Nervous System

Purposes of Nerve StimulationPromotePlasticity Peripheral Brain Spinal CordModulationMovement Control Pain Suppressiontremors orseizures Obesity Bladder Augmentrehabilitation FES Regulate

Implanted vs ExternalExternalStimulationBenefitsRisks low clinical riskeasy toimplementlower cost ImplantedStimulation targetedstimulationConsistencyease of usemobile burning of skinstimulate a large musclegroup rather thantargeteddifficult toduplicate/compliancesurgeryinfectionscar tissuehigher costcomplex

Stimulation of Peripheral NervesCommercialInvestigativeFacial MusclesXXSwallowingXXSleep ApneaXXDepressionXStroke/SCI Recovery Upper ExtremityXXBladder ManagementXXNerve Repair*XPain Management*XXGait for Drop FootXX

PENSPercutaneous Neuromodulation e.comSPR Therapeuticswww.sprtherapeutics.com

Stimulation of the BrainTMS & rTMSTranscranial Magnetic StimulationDBSDeep Brain StimulationBCI & BMIBrain Computer InterfaceBrain Machine InterfacetDCSTranscranial Direct Current Stimulation

Stimulation of the Brain - ExternalTMS – Transcranial Magnetic StimulationtDCS – Transcranial Direct Current Stimulation Magnetic stimulation on outside of brain Direct Current stimulation on outside of brain Magnetic pulses produce changes in Low level current between anode & cathodeneuron activityto produce changes in neuron activity

Stimulation of the Brain - Internal Implanted electrodes inbrain Stimulate abnormal signalsor affect cells andchemicals in the brain Various targets of thebrain. Most common issubthalamic nucleus (STN)or globus pallidus interna(GPI)

Stimulation of the Brain: Commercial Medtronic Activa DBS www.medtronic.comBoston Scientific Vercise www.bostonscientific.comSt. Jude Medical Brio www.sjm.comAleva Neurotherapeutics –www.aleva-neuro.com NeuroStar TMS Therapy System www.neuronetics.comeNeura: Spring TMS www.eneura.comMagstim - www.magstim.comCefaly - www.cefaly.usNexstim – www.nexstim.comBrainsway – www.brainsway.comRio Grand Neurosciences –riograndneuroscience.comFisher Wallace Stimulatorwww.fisherwallace.comHalo Neuroscience –www.haloneuro.comNon-FDA Approved: TCT Research Ltdwww.trans-cranial.com Cognitive Kit Cognitivekit.com Brain Stimulator theBrainStimulator.net Thync – thync.com Foc.us – www.foc.us

Stimulation of the Brain: InvestigationalCervel Neurotech rTMSwww.cervel.comSoterix Medical 1 1 tDCS Platformswww.soterixmedical.comNoted Published Studies Stroke Rehabilitation – rTMS,tDCS Incomplete SCI rTMS, tDCS Parkinson’s disease – rTMS ALS – rTMS Chronic Pain – DBS Tourette’s – DBS Huntington’s – DBS MS - DBS Psychiatric - DBS

Stimulation of the Brain: InvestigationalBattelle & OhioState NCT01997125Brain Gate fier: NCT00912041University ofPittsburghClinicalTrials.govIdentifier: NCT01894802,NCT01364480

Stimulation of the Spinal Cord Cervical spinal cord Thoracolumbar spinalcord Intrathecal

SCS - Spinal Cord StimulationMedtronic:Restore Sensorwww.tamethepain.comBoston Scientific:Precision w.stimwave.comSt. Jude .nevro.comNuvectra:Algovitawww.nuvectramed.com

Epidural Stimulation 16-electrode arrayimplanted over the L1S1 spinal cordsegments Creates sensory inputto the spinal cord,which may alter thethreshold for motorcircuitry activationSource: Harkema etal 2011, Lancet

Noted Clinical Trials Epi Stim to Facilitate Standing and Stepping,NCT02339233 The overall aim is to assess whether task specific locomotortraining and spinal cord electrical stimulation (SCES) can induceneural reorganization of the functionally isolated human spinal cordto improve standing and stepping in individuals with functionallycomplete SCI. Univ. Louisville; Cervical and Thoracic SCI Epi Stim to Recover Cardiovascular Function,NCT02037620 This study is designed to use epidural spinal cord stimulation toimprove cardiovascular and respiratory function.Source: www.ClinicalTrials.gov Univ. Louisville; Cervical SCI

Noted Clinical Trials Spinal Cord Neuromodulation for SCI, NCT02313194 This study is designed to assess the strategy of using spinal cordstimulation to improve the ability to move arms and hands in spinalcord injured humans. UCLA; Cervical SCI Stimulation with Wire Leads to Restore Cough,NCT01659541 The overall aim is to assess the efficacy of spinal cord stimulationto restore effective cough in individuals with chronic cervical SCI. Case Western Reserve Univ.; Cervical SCISource: www.ClinicalTrials.gov

Noted Clinical Trials – Non-Invasive Transcutaneous Electrical Spinal Stimulation forLower Limbs, NCT01949285 The aim is to assess whether non-invasive spinal cord electricalstimulation can be used to measure spared function in individualswith non-ambulatory SCI and if it is a useful rehabilitation tool. UCLA, NeuroEnabling Tech.; Cervical and Thoracic SCI Restoring Arm and Hand Function with Non-InvasiveSpinal Stimulation, NCT01906424 This study is designed to assess the strategy of non-invasive spinalcord stimulation to improve the ability to move arms and hands inspinal cord injured humans. UCLA, NeuroEnabling Tech.; Cervical SCISource: www.ClinicalTrials.gov

Considerations for Participatingin any Clinical Trial- Know your rights & risks: Informed Consent, Read the fine print- Understand your commitments- Manage your expectations- Beware – of “trials” that are unapproved, even in the US – just-because a US doctor is doing it does not mean it is legitimateDo your research – get a second or third opinion from aresearch center or hospitalNever pay for experimental treatmentsExpect Follow UpRefer to about-studies/learn )

Additional Resources Search Terms ClinicalTrials.gov “spinal cord injury”, “tetraplegia”, “paraplegia”AND “stimulation”, “spinal cord stimulation”, “epidural”,“neuromodulation”, “brain interface”, “TMS”, “tDCS” Miami Project:www.themiamiproject.org Link study for treatment of pain & AD forSCI using DBS Neurotech Network Condition FactSheets: www.NeurotechNetwork.orgincluding spinal cord injury, brain injury, stroke, multiplesclerosis, Parkinson’s and moreFree Download of this nts/

Kim Anderson-Erisman PhD, Director OfEducation, University Of Miami & MiamiProject To Cure Paralysis kanderson3@med.miami.eduJennifer French, MBA, ExecutiveDirector, Neurotech Networkjfrench@neurotechnetwork.orgNext Webinar is October 13, 2016: Pain and Spasticity Management

Jennifer French, MBA . Kimberly Anderson-Erisman, PhD . Want to Ask a Question? . Battelle & Ohio State University NeuroBridge ClinicalTrials.gov Identifier: NCT01997125 . Stimulation of the Spinal Cord . Jennifer French, MBA, Executive Director, Neurotech Network