Read "Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary" at NAP.edu

Page 85 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

B

Workshop Agenda

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

Page 86 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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.
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.
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).

Page 87 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

	JEFFREY NYE, Workshop Co-Chair Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation

	HANK GREELY, Workshop Co-Chair Director, Stanford Program in Neuroscience and Society Stanford University

8:40 a.m.	Mechanisms and Targets of Action Provide an overview of what is known about mechanisms and targets of action. Discuss what technology is needed to further develop the field.
	MARK HALLETT Chief, Human Motor Control Section National Institute of Neurological Disorders and Stroke

9:05 a.m.	Non-Invasive Neuromodulation Technology Provide an overview of non-invasive neuromodulation devices, including electromagnetic devices and other developing devices, such as those involving ultrasound and light.

Page 88 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

	Discuss what is known and unknown about engineering neuromodulation devices. Discuss how electrical dose and exposure of different brain locations to electric fields can be modeled.

	VICTOR KRAUTHAMER Division of Biomedical Physics Office of Science and Engineering Labs Food and Drug Administration

	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?

Page 89 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

9:55 a.m.	Panel Remarks

	ROY HAMILTON Assistant Professor of Neurology University of Pennsylvania

	SARAH “HOLLY” LISANBY Professor and Chair Department of Psychiatry & Behavioral Sciences Duke University

	ALEXANDER ROTENBERG Associate Professor of Neurology Harvard Medical School Senior Associate in Neurology Boston Children’s Hospital

	W. JEFFREY ELIAS Associate Professor of Neurological Surgery and Neurology Director of Stereotactic and Functional Neurosurgery University of Virginia School of Medicine

10:35 a.m.	Discussion Among Speakers and Workshop Participants

11:10 a.m.	BREAK

Page 90 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

11:30 a.m.	Panel Remarks

	MARK DEMITRACK Vice President and Chief Medical Officer Neuronetics

	ATUL PANDE Chief Medical Officer and Executive Vice President Tal Medical

	ANA MAIQUES Chief Executive Officer Neuroelectrics

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?

Page 91 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

1:20 p.m.	Overview Talk

	ROBERT CHEN Professor of Neurology University of Toronto

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

	ROI COHEN KADOSH Wellcome RCD Fellow and University Research Lecturer University of Oxford

	DANIEL WETMORE Director, Intellectual Property and Usability Thync

	MICHAEL FOX Assistant Professor of Neurology Harvard University

2:20 p.m.	Discussion Among Speakers and Workshop Participants

2:45 p.m.	BREAK

Page 92 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

	Regulatory Pathways for Non-Invasive Devices
	How does the regulatory landscape contrast for non-invasive devices versus other medical devices? What is the current regulatory position regarding the balance between risk and benefit standards of evidence and fostering innovation? How are medical devices defined in the context of regulatory approval? When do preexisting device-based indications (e.g., presurgical mapping) impact other potential uses? What regulatory oversight exists for over-the-counter use? What are the regulatory issues regarding combination non-invasive neuromodulation devices and pharmaceutical therapies? Consider country differences in regulatory pathways, including How are regulatory pathways for noninvasive neuromodulation devices different?

Page 93 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

	What challenges exist for companies targeting domestic and foreign markets? What is the impact of differences in regulations? How does the Food and Drug Administration coordinate with overseas regulatory agencies?

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

	What levels of evidence are needed to warrant clinical use? What considerations are important when designing clinical trials (e.g., timing, length, magnitude)? What challenges exist for developing clinical trials for non-invasive neuromodulation devices? How can clinical trials be conducted effectively?
	JASON CONNOR Adaptive Clinical Trial Designer Berry Consultants

3:55 p.m.	Discussion Among Speakers and Workshop Participants

5:00 p.m.	Day-One Wrap-Up

	Workshop Co-Chairs

5:15 p.m.	ADJOURN DAY ONE

Page 94 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

8:40 a.m.	Neuromodulation, the Self, and Enhancement
	Explore questions about the use of these devices and the impact on “self.” Consider the impact of use of these devices for enhancement in individuals without an impaired baseline. Identify ways of incorporating these considerations into the development and use of non-invasive neuromodulation devices.
	ERIK PARENS Senior Research Scholar The Hastings Center

	MARTHA FARAH Walter H. Annenberg Professor of Natural Sciences University of Pennsylvania

Page 95 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

9:20 a.m.	Neuromodulation and Unsupervised Use
	What are considerations when using noninvasive neuromodulation devices outside of therapeutic use? What are potential risks for use of these devices by consumers? Are there differences in risks/benefits between clinical oversight and non-clinical settings? How well are users protected from potential malfunctions?
	HANNAH MASLEN Postdoctoral Research Fellow in Ethics Oxford Center for Neuroethics

9:40 a.m.	Neuromodulation and Coercion
	Consider the impact of use in vulnerable populations (e.g., in children or individuals with mental illness) or involuntary use of these devices (e.g., court ordered or psychiatrist ordered).
	JENNIFER CHANDLER Professor of Law University of Ottawa

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.

Page 96 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

10:45 a.m.	Session Overview and Objectives

	RHONDA ROBINSON-BEALE, Session Moderator Senior Vice President and Medical Officer Blue Cross of Idaho

10:50 a.m.	Current Reimbursement Practices
	Are payors currently reimbursing for these treatments? How are insurance companies currently evaluating these treatments in comparison to other options? Are there state differences in reimbursement practices? What is the impact of non-reimbursement?
	RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho

	OSCAR MORALES Founding Director, Transcranial Magnetic Stimulation Service McLean Hospital

11:20 a.m.	Improving the Evidence Base for Reimbursement
	What is the current evidence base used for reimbursement? What evidence is needed from research to align with insurance policies and evidence criteria? How might greater information of comparative effectiveness between these devices and other therapeutics impact reimbursement practices?
	RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho

Page 97 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

	BRADLEY GAYNES Professor of Psychiatry Associate Chair of Research Training and Education University of North Carolina at Chapel Hill School of Medicine

11:50 a.m.	Industry Panel
	What is the impact of non-reimbursement or of reimbursement that is fragmented regionally or internationally? How do reimbursement decision-making processes differ for pharmaceutical products and medical devices, given the differences in safety profile (i.e., the view of regulators)? How different do devices need to be for independent assessments and how important is pooling of studies of devices with a similar mechanism?
	MARY HAILEY Vice President of Health Policy and Government Relations Neuronetics

	ERIC LIEBLER Vice President, Scientific, Medical, and Governmental Affairs electroCore

	JOHN REPPAS Director of Public Policy Neurotechnology Industry Organization

12:20 p.m.	Discussion Among Speakers and Workshop Participants

12:45 p.m.	LUNCH

Page 98 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

	JEFFREY NYE, Workshop Co-Chair Vice President Neuroscience Innovation and Scientific Partnership Strategy Janssen Research and Development, LLC Johnson & Johnson Innovation

	FRANCES JENSEN Professor and Chair of Neurology Perelman School of Medicine University of Pennsylvania

	HANK GREELY, Workshop Co-Chair Director, Stanford Program in Neuroscience and Society Stanford University

	RHONDA ROBINSON-BEALE Senior Vice President and Medical Officer Blue Cross of Idaho

Page 99 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×

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

Page 100 Cite

Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2015. Non-Invasive Neuromodulation of the Central Nervous System: Opportunities and Challenges: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21767.

×