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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
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Appendix B

Workshop Agenda

EXPLORING THE ADOPTION OF IMPLANTABLE BRAIN STIMULATION INTO STANDARD OF CARE FOR CENTRAL NERVOUS SYSTEM DISORDERS

The Keck Center, 500 Fifth Street, NW
Washington, DC 20001

OCTOBER 31, 2023
ROOM 100

9:00–9:05 Welcome
Frances Jensen, University of Pennsylvania; Co-chair, Forum on Neuroscience and Nervous System Disorders
John Krystal, Yale University; Co-chair, Forum on Neuroscience and Nervous System Disorders

SESSION 1—CROSSING THE CHASM: LESSONS LEARNED ACROSS TECHNOLOGIES

  • Review the current state of knowledge regarding the clinical utilization of implantable brain stimulation across various CNS disorders and consider the future potential to improve quality of life for patients.
  • Discuss the lessons learned from other technologies that have or have not “crossed the chasm” to be adopted into clinical care.
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
  • Consider how these lessons learned might be applied to implantable brain stimulation.
9:05–9:15 Workshop Overview
Tim Denison, University of Oxford; Workshop Co-chair
Helen Mayberg, Icahn School of Medicine at Mount Sinai; Workshop Co-chair
  • Share the scope of the workshop and what will not be covered.
  • Introduce technology adoption theory as the theme for this workshop.
  • Highlight that scalability, technology, comorbidities considerations, and opportunities to overcome these barriers will be implicit throughout the workshop.
9:15–9:20 Setting the Stage: Where Do We Want to Be
Brian Litt, University of Pennsylvania
  • What does it mean to be a part of the standard of care?
  • Provide a brief history about cardiac pacemakers and defibrillators.
  • What would be required for implantable brain stimulation to be adopted into the standard of care?
9:20–9:45 Lessons Learned Across Therapeutic Areas
  • Provide an overview of the therapy and the patient need that was being addressed.
  • Share insights into why the therapy has been or not been adopted into clinical care.
  • What are some of the lessons learned that should be considered for any new implantable brain stimulation therapy?
Overview of Approved Neuromodulation Therapies
Vivek Pinto, U.S. Food and Drug Administration
Cochlear Implants and Retinal Implants
Carla Mann Woods, Adventus Ventures
Responsive Neurostimulation for Epilepsy
Mindy Ganguly, University of Pennsylvania
Deep Brain Stimulation for Obsessive-Compulsive Disorder (OCD)
Benjamin Greenberg, Brown University
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
9:45–10:00 Moderated Discussion
Moderator: Brian Litt, University of Pennsylvania

SESSION 2—BENEFITS AND CHALLENGES EXPERIENCED BY INDIVIDUALS WITH LIVED EXPERIENCE

  • Explore what patients need from implantable brain stimulation to define it as a successful treatment.
  • Discuss how adoption of this technology can impact patients and their quality of life.
  • Consider what challenges and barriers prevent patients from selecting this treatment or causes patients to perceive the treatment as a failure.
10:00–10:05 Session Overview
Laura Lubbers, CURE Epilepsy
10:05–10:25 Speaker Remarks
Steve Austin, CURE Epilepsy
Jim McNasby, Michael J. Fox Foundation for Parkinson’s Research
Jon Nelson, Jon Nelson Advisors, LLC
Claudia Garrido-Revilla, Michael J. Fox Foundation for Parkinson’s Research
10:25–10:55 Moderated Discussion
10:55–11:05 Break

SESSION 3—PRACTICAL BARRIERS I: PATIENT SELECTION AND ENGAGEMENT

  • Review the challenges associated with patient selection and engagement and with managing expectations of patients and their families.
  • Consider the ethics of ensuring equitable access to all patients and demographics.
  • Explore the potential opportunities or collaborations that are needed to develop informed patient selection practices and equitable access to the technology.
  • Review the concerns of patients regarding the possible complications and side effects of implantable brain stimulation and potential educational campaigns to increase patient awareness of and comfort with the technology.
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
11:05–11:10 Session Overview
Sarah Perides, Evelina London’s Children Hospital
11:10–12:10 Moderated Panel and Audience Q&A
Joseph Candelario-Mckeown, National Hospital for Neurology and Neurosurgery
Rachel Davis, University of Colorado Anschutz School of Medicine
Nita Farahany, Duke University (Zoom)
Doris Wang, University of California, San Francisco (Zoom)
Alik Widge, University of Minnesota
12:10–12:55 Lunch

SESSION 4—PRACTICAL BARRIERS II: HEALTH PROFESSIONAL BARRIERS AND ADOPTION

  • Discuss the current barriers to increase training and engagement among health professionals on implantable brain stimulation and barriers of current practices.
  • Explore what relationships might need to be developed across different specialties and clinical practices to facilitate referrals and continuance of care.
12:55–1:00 Session Overview
David McMullen, Food and Drug Administration
1:00–2:00 Moderated Panel and Audience Q&A
Lauren Hammer, University of California, San Francisco (Zoom)
Joan Miravite, Icahn School of Medicine at Mount Sinai
Martha Morrell, NeuroPace, Inc.
Michael Okun, University of Florida
Yagna Pathak, Abbott Neuromodulation
2:00–2:10 Break

SESSION 5—PRACTICAL BARRIERS III: REIMBURSEMENT AND OTHER ECONOMIC CONSIDERATIONS

  • Consider the current economic barriers and technological limitations that prevent implantable brain stimulation from becoming scalable.
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
  • Discuss what ongoing or future approaches need to be taken to improve the benefit-cost ratio and allow brain stimulation to be scalable for wider application in CNS disorders.
  • Review the current status of reimbursement for implantable brain stimulation and discuss opportunities to increase reimbursement.
2:10–2:15 Session Overview
Yagna Pathak, Abbott Neuromodulation
2:15–3:15 Moderated Panel and Audience Q&A
Julie Brown, Spark Biomedical (Zoom)
Kevin Mahoney, University of Pennsylvania Health System
Susan Miller, Centers for Medicare & Medicaid Services (Zoom)
Peter Silburn, Queensland Brain Institute (Zoom)
3:15–3:25 Break

SESSION 6—SYNTHESIS OF WORKSHOP THEMES

  • Review the core themes and takeaways shared across the previous sessions.
  • Based on previous discussions, explore creative approaches or collaborations needed to move the field forwards toward the end goal of adoption of implantable brain stimulation into the standard of care.
  • Discuss the implications of comorbidities and opportunities to develop technologies and treatments to holistically treat patients.
3:25–3:30 Session Overview
Tim Denison, University of Oxford; Workshop Co-chair
Helen Mayberg, Icahn School of Medicine at Mount Sinai; Workshop Co-chair
3:30–4:25 Moderated Panel and Audience Q&A
Brandy Ellis, Neuromodulation Patient Advocate
Lauren Hammer, University of California, San Francisco (Zoom)
Doug Kelly, Food and Drug Administration
Sarah Hollingsworth Lisanby, National Institute of Mental Health
Kevin Mahoney, University of Pennsylvania Health System
Chris Pulliam, Case Western University
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
4:25–4:30 Synthesis and Concluding Remarks
Tim Denison, University of Oxford; Workshop Co-chair
Helen Mayberg, Icahn School of Medicine at Mount Sinai; Workshop Co-chair
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
Page 73
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
Page 74
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
Page 75
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
Page 76
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
Page 77
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27657.
×
Page 78
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Implantable brain stimulation has had a profound impact on neuroscience research and the treatment of central nervous system disorders by allowing physicians to directly intervene in the pathological neural circuits of their patients. To explore the logistical, educational, and economic barriers to adopting this technology into regular use in clinical care, the National Academies Forum on Neuroscience and Nervous System Disorders hosted a public workshop in October 2023.

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