Kimberly Anderson-Erisman, PhD Director of Education University of Miami & Miami Project to Cure Paralysis

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1 Webinar title: Direct Nerve Stimulation What is it really and what is the potential? Presenter/presenters: Kimberly Anderson-Erisman, PhD Director of Education University of Miami & Miami Project to Cure Paralysis Jennifer French, MBA Executive Director Neurotech Network

2 Want to Ask a Ques-on?

3 Disclaimer page The informa,on presented in this webinar is not meant to replace the advice from a medical professional. You should consult a health care professional familiar with your specific case, concerns and condi,on. Neurotech Network and its representa,ves do not endorse, rate, sell, distribute, prescribe, administer or recommend any products, procedures or services. We highly suggest for you to take informa,on to a trained medical professional familiar with your case to discuss op,ons that are best for you.

4 The Miami Project is dedicated to finding more effec-ve treatments and, ul-mately, a cure for paralysis resul-ng from spinal cord injury. Helping people regain life thru neurotechnology Focusing on educa-on of and advocacy to access neurotechnology devices, therapies and treatments for people living with impairments, their care- givers and medical professionals.

5 Objec-ves Understanding the Human Nervous System Introduce various purposes of s-mula-on to a nerve Differen-ate implanted from external s-mula-on Technology applica-ons Peripheral Brain Spinal Cord Resources to learn more

6 The Human Nervous System

7 The Human Nervous System

8 Purposes of Nerve S-mula-on Promote Plasticity Peripheral Brain Spinal Cord Modulation Movement Control Pain Suppression tremors or seizures Obesity Bladder Augment rehabilitation FES Regulate

9 Implanted vs External Benefits Risks External Stimulation low clinical risk easy to implement lower cost burning of skin stimulate a large muscle group rather than targeted difficult to duplicate/ compliance Implanted Stimulation targeted stimulation Consistency ease of use mobile surgery infection scar tissue higher cost complex

10 S-mula-on of Peripheral Nerves Commercial Investigative Facial Muscles X X Swallowing X X Sleep Apnea X X Depression X Stroke/SCI Recovery Upper Extremity X X Bladder Management X X Nerve Repair* X Pain Management* X X

11 PENS Percutaneous Neuromodulation Systems Algotec ltd.com Biowave SPR Therapeu-cs

12 S-mula-on of the Brain TMS & rtms Transcranial Magnetic Stimulation DBS Deep Brain Stimulation BCI & BMI Brain Computer Interface Brain Machine Interface tdcs Transcranial Direct Current Stimulation

13 S-mula-on of the Brain - External TMS Transcranial Magnetic Stimulation tdcs 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 & cathode neuron activity to produce changes in neuron activity

14 S-mula-on of the Brain - Internal Implanted electrodes in brain Stimulate abnormal signals or affect cells and chemicals in the brain Various targets of the brain. Most common is subthalamic nucleus (STN) or globus pallidus interna (GPI)

15 S-mula-on of the Brain: Commercial Fisher Wallace S-mulator Medtronic Activa DBS Boston Scientific Vercise St. Jude Medical Brio NeuroStar TMS Therapy System - eneura: Spring TMS - Mags-m - Cefaly - Non- FDA Approved: TCT Research Ltd cranial.com Cogni-ve Kit Cogni-vekit.com Brain S-mulator thebrains-mulator.net

16 S-mula-on of the Brain: Inves-ga-onal Cervel Neurotech rtms Soterix Medical 1 1 tdcs Pla[orms Noted 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

17 S-mula-on of the Brain: Inves-ga-onal Battelle & Ohio State University NeuroBridge ClinicalTrials.gov Identifier: NCT Brain Gate Brown University MultiCenter ClinicalTrials.gov Identifier: NCT University of Pittsburgh ClinicalTrials.gov Identifier: NCT , NCT

18 S-mula-on of the Spinal Cord Cervical spinal cord Thoracolumbar spinal cord Intrathecal

19 SCS - Spinal Cord Stimulation St. Jude Medical: Boston Scien-fic: Medtronic: Eon Precision Spectra Restore Sensor S-mWave: Freedom- 4 Nevro: Senza Spinal Modula-on: Axium

20 Epidural Stimulation 16-electrode array implanted over the L1S1 spinal cord segments Creates sensory input to the spinal cord, which may alter the threshold for motor circuitry activation Source: Harkema etal 2011, Lancet

21 Noted Clinical Trials Epi Stim to Facilitate Standing and Stepping, NCT The overall aim is to assess whether task specific locomotor training and spinal cord electrical stimulation (SCES) can induce neural reorganization of the functionally isolated human spinal cord to improve standing and stepping in individuals with functionally complete SCI. Univ. Louisville; Cervical and Thoracic SCI Spinal Cord Neuromodulation for SCI, NCT This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans. UCLA; Cervical SCI Source:

22 Considera-ons for Par-cipa-ng in 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 legitimate - Do your research get a second or third opinion from a research center or hospital - Never pay for experimental treatments - Expect Follow Up - Refer to ClinicalTrials.gov (https://clinicaltrials.gov/ct2/about-studies/learn )

23 Addi-onal Resources Search Terms ClinicalTrials.gov spinal cord injury, tetraplegia, paraplegia AND stimulation, epidural, neuromodulation, brain interface, TMS, tdcs Miami Project: Link study for treatment of pain & AD for SCI using DBS Neurotech Network Condition Fact Sheets: including spinal cord injury, brain injury, stroke, multiple sclerosis, Parkinson s and more Free Download of this booklet document.doc?id=368

24 Ø Ø Kim Anderson-Erisman PhD, Director Of Education, University Of Miami & Miami Project To Cure Paralysis Ø Ø Jennifer French, MBA, Executive Director, Neurotech Network Next Webinar is September 30, 2015: Vibration Therapy

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