Non-Invasive Neuromodulation of the Central Nervous
System: A Workshop
March 2 and 3, 2015
Institute of Medicine
500 Fifth Street, NW, Room 100
Washington, DC 20001
Background:
Based on advances in biotechnology and neuroscience, neuromodulation devices are poised to gain clinical importance in the coming years and to be of increasing interest to patients, health care providers and payers, and industry. Emerging evidence suggests that the potential therapeutic and non-therapeutic uses of non-invasive neuromodulation devices for the central nervous system are broad and will continue to expand. Along with the growing number of opportunities, there are challenges and open questions associated with the use of these devices. Currently, there is a need for greater understanding of the potential benefits and risks; in particular, of the short- and long-term impact of using these devices. From a regulatory standpoint, there are scientific and clinical questions that are important for regulatory approval and usability for consumers. A third area of consideration is the existing, and appropriate, levels of evidence for reimbursement. Several issues raise ethical questions, including the potential for off-label, over-the-counter, or do-it-yourself uses or for enhancement. Given the growing interest in non-invasive neuromodulation devices for the central nervous system, the goal of this workshop is to explore opportunities, challenges, and ethical questions
surrounding the development, regulation, and reimbursement of such devices.
Meeting Objectives:
- Highlight potential benefits and risks of non-invasive neuromodulation based on known short- and long-term central nervous system mechanisms of action.
- Explore the scientific landscape of non-invasive neuromodulation device development for both therapeutic and non-therapeutic uses.
- Consider issues concerning vulnerable populations.
- Explore the scientific landscape of non-invasive neuromodulation device development for both therapeutic and non-therapeutic uses.
- Consider the regulatory landscape for non-invasive neuromodulation devices.
- Discuss potential outcome measures for therapeutic uses in regulatory processes.
- Explore pathways for regulatory approval of therapies using a combination of non-invasive neuromodulation devices and pharmaceuticals.
- Discuss differences in regulatory pathways among countries.
- Explore current and potential use reimbursement practices for therapeutic use of non-invasive neuromodulation devices.
- Explore the evidence base and acceptable therapeutic outcome measures used in reimbursement decisions.
- Consider economic outcome measures used to determine payer practices.
- Explore the evidence base and acceptable therapeutic outcome measures used in reimbursement decisions.
- Examine ethical questions about the use of non-invasive neuromodulation devices.
- Consider ethical issues of off-label and over-the-counter use on regulation, reimbursement, and patient safety.
- Discuss the use of these devices for enhancement in individuals without an impaired baseline.
- Consider the implications of involuntary or coercive use (e.g., children, court-ordered treatment).
- Consider ethical issues of off-label and over-the-counter use on regulation, reimbursement, and patient safety.
March 2, 2015 | |
8:30 a.m. | Opening Remarks |
ALVARO PASCUAL-LEONE, Workshop Co-Chair Professor of Neurology Associate Dean for Clinical and Translational Research Harvard Medical School |
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JEFFREY NYE, Workshop Co-Chair Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation |
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HANK GREELY, Workshop Co-Chair Director, Stanford Program in Neuroscience and Society Stanford University |
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8:40 a.m. |
Mechanisms and Targets of Action
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MARK HALLETT Chief, Human Motor Control Section National Institute of Neurological Disorders and Stroke |
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9:05 a.m. |
Non-Invasive Neuromodulation Technology
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VICTOR KRAUTHAMER Division of Biomedical Physics Office of Science and Engineering Labs Food and Drug Administration |
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LEONARDO ANGELONE Division of Biomedical Physics Office of Science and Engineering Labs Food and Drug Administration |
SESSION I: THERAPEUTIC AND NON-THERAPEUTIC USES
Session Objectives: Discuss potential benefits and risks of non-invasive neuromodulation devices based on known short- and long-term central nervous system mechanisms of action. Explore the scientific landscape of device development for both therapeutic and non-therapeutic uses. Discuss the scientific controversies behind the potential uses. Consider issues concerning vulnerable populations.
Part One: Therapeutic Uses: Current and Developing
- What are common clinical applications of non-invasive neuromodulation devices?
- What are the known benefits and risks associated with use? What are the scientific controversies behind this evidence?
- Are mechanisms and outcomes of use different between adults and children?
- What opportunities and challenges exist around increasing understanding of effects of treatment?
- “In place of current therapeutics”: How do non-invasive neuromodulation devices compare to current treatment options?
- “In combination with current therapeutics”: What is the potential for use in combination with other therapies, and what is known about interactions?
9:30 a.m. | Overview Talk and Session Objectives |
ALVARO PASCUAL-LEONE, Moderator Professor of Neurology Associate Dean for Clinical and Translational Research Harvard Medical School |
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9:55 a.m. | Panel Remarks |
ROY HAMILTON Assistant Professor of Neurology University of Pennsylvania |
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SARAH “HOLLY” LISANBY Professor and Chair Department of Psychiatry & Behavioral Sciences Duke University |
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ALEXANDER ROTENBERG Associate Professor of Neurology Harvard Medical School Senior Associate in Neurology Boston Children’s Hospital |
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W. JEFFREY ELIAS Associate Professor of Neurological Surgery and Neurology Director of Stereotactic and Functional Neurosurgery University of Virginia School of Medicine |
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10:35 a.m. | Discussion Among Speakers and Workshop Participants |
11:10 a.m. | BREAK |
Part Two: Developing Non-Invasive Neuromodulation Devices for Therapeutic Uses
- What is the level of interest in development of these devices?
- What are the opportunities and barriers to development?
11:25 a.m. | Session Overview and Objectives |
JEFFREY NYE, Moderator Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation |
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11:30 a.m. | Panel Remarks |
MARK DEMITRACK Vice President and Chief Medical Officer Neuronetics |
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ATUL PANDE Chief Medical Officer and Executive Vice President Tal Medical |
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ANA MAIQUES Chief Executive Officer Neuroelectrics |
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12:00 p.m. | Discussion Among Speakers and Workshop Participants |
12:30 p.m. | LUNCH |
Part Three: Non-Medical and Investigational Uses
- What is the type and extent of non-medical use?
- What are the known benefits and risks associated with use?
- What opportunities and challenges exist around non-therapeutic use, including over-the-counter and consumer-initiated use?
- Are mechanisms and outcomes of use different between adults and children?
- How is non-invasive neuromodulation used for diagnostic and investigational purposes?
1:15 p.m. | Session Overview and Objectives |
FRANCES JENSEN, Moderator Professor and Chair of Neurology Perelman School of Medicine University of Pennsylvania |
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1:20 p.m. | Overview Talk |
ROBERT CHEN Professor of Neurology University of Toronto |
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1:40 p.m. | Panel Remarks |
DYLAN EDWARDS Director, Laboratory for Non-Invasive Brain Stimulation and Human Motor Control Burke Medical Research Institute Associate Professor, Department of Neurology Weill Cornell Medical College |
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ROI COHEN KADOSH Wellcome RCD Fellow and University Research Lecturer University of Oxford |
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DANIEL WETMORE Director, Intellectual Property and Usability Thync |
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MICHAEL FOX Assistant Professor of Neurology Harvard University |
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2:20 p.m. | Discussion Among Speakers and Workshop Participants |
2:45 p.m. | BREAK |
SESSION II: REGULATORY
Session Objectives: Consider the regulatory landscape for non-invasive neuromodulation devices. Discuss potential outcome measures for therapeutic uses in regulatory processes, pathways for regulatory approvals for therapies using a combination of non-invasive neuromodulation devices and pharmaceuticals, and differences in regulatory pathways among countries, then consider the impact.
3:00 p.m. | Session Overview and Objectives |
JEFFREY NYE, Session Moderator Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation |
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Regulatory Pathways for Non-Invasive Devices | |
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3:05 p.m. |
TIMOTHY MARJENIN Chief, Neurostimulation Devices Branch Food and Drug Administration |
3:25 p.m. |
IBIM TARIAH Technical Director British Standards Institution |
3:40 p.m. | Conducting Clinical Trials |
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JASON CONNOR Adaptive Clinical Trial Designer Berry Consultants |
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3:55 p.m. | Discussion Among Speakers and Workshop Participants |
5:00 p.m. | Day-One Wrap-Up |
Workshop Co-Chairs |
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5:15 p.m. | ADJOURN DAY ONE |
March 3, 2015 | |
8:30 a.m. | Day Two Opening |
Workshop Co-Chairs
SESSION III: ETHICAL CONSIDERATIONS
Session Objectives: Examine ethical questions around the use of noninvasive neuromodulation devices. Consider ethical issues of off-label and over-the-counter use on regulation, reimbursement, and patient safety. Discuss the use of these devices for enhancement in individuals without an impaired baseline. Consider the implications of involuntary or coercive use.
8:35 a.m. | Session Overview and Objectives |
HANK GREELY, Session Moderator Director, Stanford Program in Neuroscience and Society Stanford University |
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8:40 a.m. | Neuromodulation, the Self, and Enhancement |
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ERIK PARENS Senior Research Scholar The Hastings Center |
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MARTHA FARAH Walter H. Annenberg Professor of Natural Sciences University of Pennsylvania |
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9:20 a.m. | Neuromodulation and Unsupervised Use |
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HANNAH MASLEN Postdoctoral Research Fellow in Ethics Oxford Center for Neuroethics |
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9:40 a.m. | Neuromodulation and Coercion |
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JENNIFER CHANDLER Professor of Law University of Ottawa |
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10:00 a.m. | Discussion Among Speakers and Workshop Participants |
10:30 a.m. | Break |
SESSION IV: REIMBURSEMENT
Session Objectives: Explore current and potential use reimbursement practices for therapeutic uses of non-invasive neuromodulation devices. Explore the evidence base and acceptable therapeutic outcome measures used in reimbursement decisions. Consider economic outcome measures used to determine payer practices.
10:45 a.m. | Session Overview and Objectives |
RHONDA ROBINSON-BEALE, Session Moderator Senior Vice President and Medical Officer Blue Cross of Idaho |
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10:50 a.m. | Current Reimbursement Practices |
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RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho |
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OSCAR MORALES Founding Director, Transcranial Magnetic Stimulation Service McLean Hospital |
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11:20 a.m. | Improving the Evidence Base for Reimbursement |
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RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho |
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BRADLEY GAYNES Professor of Psychiatry Associate Chair of Research Training and Education University of North Carolina at Chapel Hill School of Medicine |
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11:50 a.m. | Industry Panel |
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MARY HAILEY Vice President of Health Policy and Government Relations Neuronetics |
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ERIC LIEBLER Vice President, Scientific, Medical, and Governmental Affairs electroCore |
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JOHN REPPAS Director of Public Policy Neurotechnology Industry Organization |
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12:20 p.m. | Discussion Among Speakers and Workshop Participants |
12:45 p.m. | LUNCH |
1:15 p.m. | Non-Invasive Neuromodulation: A Venture Capitalist’s Perspective |
ROSS JAFFE Managing Director Versant Ventures |
SESSION V: MOVING FORWARD
Session Objectives: A panel will synthesize and discuss key highlights from the workshop presentations and discussions, including identifying next steps and promising areas for future action and research.
1:35 p.m. | Panel Discussion: Session Moderators |
ALVARO PASCUAL-LEONE, Workshop Co-Chair Professor of Neurology Associate Dean for Clinical and Translational Research Harvard Medical School |
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JEFFREY NYE, Workshop Co-Chair Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation |
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FRANCES JENSEN Professor and Chair of Neurology Perelman School of Medicine University of Pennsylvania |
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HANK GREELY, Workshop Co-Chair Director, Stanford Program in Neuroscience and Society Stanford University |
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RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho |
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2:25 p.m. | Discussion Among Speakers and Workshop Participants |
2:45 p.m. | Closing Remarks from the Workshop Co-Chairs |
3:00 p.m. | Adjourn Workshop |
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