Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders Proceedings of a Workshop (2024) / Chapter Skim
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7 Potential Next Steps to Move the Field Forward
7 Potential Next Steps to Move the Field Forward
Pages 59-68
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From page 59... ...
• There is a need for more objective outcome measures, such as with biomarkers, in both the research and the regulatory arena. (Lisanby)
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From page 60... ...
Helen Mayberg and Tim Denison asked participants to reflect on the core themes and takeaways from the workshop and explore creative approaches or collaborations needed to move the field forwards toward the adoption of implantable brain stimulation into the standard of care across central nervous system disorders. Workshop participants also discussed the implications of comorbidities and opportunities to develop technologies and treatments to holistically treat patients.
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From page 61... ...
New technological capabilities will make it possible to do many things that were not previously possible, such as data from sensors offering unique insights into physiology, but the emphasis should always be on improving care for patients. A REGULATORY PERSPECTIVE Doug Kelly, deputy director of the Center for Devices and Radiological Health of the FDA, began by describing his background, which included being a venture capitalist in Silicon Valley, starting several companies himself, and working as a physician and in a laboratory.
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From page 62... ...
It may take a little more time to generate that, but you will suffer so much less failure and so much less time in unprofitability. You can't have a product that makes it out to patients unless it is profitable, and people make money doing it." The goal of TAP, he said, is to "figure out those things up front and figure out the most efficient path forward." A FUNDER'S PERSPECTIVE When reflecting on the workshop discussions, Sarah Hollingsworth Lisanby, the director of the Noninvasive Neuromodulation Unit and the Division of Translational Research at the National Institutes of Mental Health, organized the themes into the four R's: research, regulation, reimbursement, and real world.
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From page 63... ...
Making things more efficient is not always the most exciting thing to work on, said Hammer, "but it is something I think is really important for us to be focusing on." The third topic she identified was economic considerations. Overcoming the financial hurdles facing the technologies will require various approaches, including creating various incentives and making the devices more efficient, noted Hammer.
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From page 64... ...
People in her situation tend to get referred to the National Alliance on Mental Illness2 1 Monoamine oxidase inhibitors are a class of effective and well-studied drugs that include the first antidepressants developed. They work by inhibiting the action of monoamine oxidases, enzymes that remove dopamine, serotonin, and norepinephrine from the brain; thus, MAOIs act to increase the levels of dopamine, serotonin, and norepinephrine in the brain.
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From page 65... ...
"As someone who watches the news, I'm not real confident in the 911 response to a mental health emergency." Even once she was enrolled in a clinical trial, Ellis said, she faced many obstacles. "My parents had to be willing to sign a payer agreement for over $75,000 for me to be admitted in case my insurance didn't cover my inpatient stay." Furthermore, her parents paid for her to move to Atlanta and supported her while she was out of work because clinical trial participants are not compensated.
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From page 66... ...
In psychiatry, she said, when researchers doing clinical trials rely exclusively on subjective symptom-based diagnosis and outcome measures, it often leads to a significant amount of heterogeneity within diagnoses and comorbidity across diagnoses and fails to map well onto brain circuitry. Objective biomarkers can be used to reduce that heterogeneity and inform treatment decisions.
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From page 67... ...
bioethics, post-clinical-trial responsibility, mental health care, patient advocacy." She ended by saying, "I want all of you to continue to do the work you are doing because this is absolutely meaningful treatment that absolutely is critical for people to survive and enjoy life." Mahoney closed out the discussion period. "I'm inspired by opportunities and want to keep pushing forward," he said.
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From page 68... ...
"I think it is appropriate to close out the workshop to recognize them. They are the true pioneers supporting this entire ecosystem." PREPUBLICATION COPY -- Uncorrected Proofs
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