The NIH BRAIN Initiative has made a substantial investment to accelerate the development of adaptive deep brain stimulation (aDBS) systems for improving clinical management of treatment-resistant psychiatric and motor disorders.
aDBS systems have emerged as a promising alternative to address significant limitations in conventional open-loop DBS treatment of neuropsychiatric and movement disorders. Studies suggest that open-loop DBS systems can effectively manage treatment-resistant obsessive-compulsive disorder, depression, Parkinson’s disease, Tourette syndrome, and essential tremor, among other disorders.
Unlike DBS, aDBS can record neural activity or other symptom-related markers to adjust stimulation in real time. Therefore, aDBS could provide stimulation only when necessary, avoid overtreatment, and minimize programming trial and error, and potential side effects (e.g. hypomania, changes in personality). In addition, aDBS can lead to improved clinical responses over DBS because it adjusts automatically, thus, it avoids the delay between suboptimal symptom management and adjustment of stimulation in a clinical encounter.
Safe and effective aDBS systems would be a welcomed advance for many patients with neuropsychiatric and movement disorders, but these systems potentially generate difficult ethical challenges that require attention.
Many of the features that make aDBS promising may exacerbate some of the ethical, legal, and social (“neuroethics”) concerns that have been raised about conventional open-loop DBS (e.g. dehumanization, changes in personal identity/personality, changes in participants’ sense of authenticity). aDBS also raises novel issues, which may impact uptake of this new technology, such as the privacy and ownership of recorded neural activity, and if patients have some control over stimulation, the potential for human enhancement by excessive manipulation of symptoms.
Although theoretical bioethics work has explored ethical and policy implications of conventional open-loop DBS for treating various disorders, there is little empirical neuroethics research in this area, and there is a severe lack of neuroethics and policy research about aDBS.
The long-term goal of our research program is to develop an ethically-justified and empirically-informed policy framework for the responsible research and translation of aDBS. The objective of this project, which is the first logical step in pursuit of that goal, is to critically evaluate whether pressing neuroethics issues related to aDBS, as identified by key stakeholders, are adequately addressed by current policy and what new policies are needed.
To achieve this objective, we are collaborating with five clinical trials that are developing aDBS for managing the symptoms of various neuropsychiatric and movement disorders: OCD (Dr. Wayne Goodman, Baylor College of Medicine); Depression and Parkinson’s Disease (Dr. Philip Starr, University of California San Francisco); Tourette’s Syndrome (Dr. Michael Okun, University of Florida); and Essential Tremor (Dr. Aysegul Gunduz, University of Florida).
Supported by: R01MH114854, Grant funding from BRAIN Initiative - National Institute of Mental Health of the National Institutes of Health
Barbara A. Koenig, R.N., Ph.D., Co-Investigator (University of California, San Francisco)
Phillip Starr, Ph.D., M.D., Co-Investigator (University of California, San Francisco)
Michael Okun, M.D., Co-Investigator (University of Florida)
Aysegul Gunduz, Ph.D., Co-Investigator (University of Florida)
Stacey Pereira, Ph.D., Co-Investigator
Cody Brannan, Research Coordinator
Jill Oliver Robinson, M.A., Research Manager
Peter Zuk, Project Intern
Lázaro-Muñoz G, McGuire AL, Goodman WK. "Should We Be Concerned About Preserving Agency and Personal Identity in Patients with Adaptive Deep Brain Stimulation Systems?" AJOB Neuroscience. 2017;8(2):73-75.
Lázaro-Muñoz G. BRAIN Initiative: Neurotechnologies and Neuroethics. University of Puerto Rico School of Medicine, Institute of Bioethics; San Juan, PR. February 2018.
Lázaro-Muñoz G. Right or Privilege? Continued Access to Investigational Brain Implants. University of Puerto Rico School of Law; San Juan, PR. February 2018.
Lázaro-Muñoz G. The Need for Empirical Data When Examining the Neuroethics of Adaptive Deep Brain Stimulation (aDBS) Systems. International Neuroethics Society Meeting. Washington, DC. November 2018.
Lázaro-Muñoz G. From Neuroscience to Neuroethics. Marine Biological Laboratory; Woods Hole, MA. 2017.