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A two-day consensus conference was held in order to examine scientific and ethical issues in the application of deep brain stimulation in the treatment of mood and behavioral disorders such as major depression, obsessive-compulsive disorder, and Tourette syndrome. The primary objectives of the conference were to 1) establish consensus among participants about the design of future clinical trials of DBS for disorders of mood, behavior and thought and 2) develop standards for the protection of human subjects participating in such studies. Conference participants identified 16 key points for guiding research in this growing field.
A National Institutes of Health and Dana Foundation–sponsored consensus conference, “Deep Brain Stimulation for Disorders of Mood, Behavior and Thought: Scientific and Ethical Issues,” which was held in autumn 2007, explored concerns relating to the study of deep brain stimulation (DBS) as a potential treatment for disorders of mood, behavior and thought (MBT). The agenda combined brief presentations with extensive periods of open discussion. The participants included leading clinical investigators from different centers in the US and Europe, bioethicists, patient advocates, research policymakers, psychiatrists, neurologists, and other experts.
The stated aims of this meeting were: 1) to establish consensus among participants about the design of future clinical trials of DBS for disorders of MBT, including inclusion criteria and whether randomized, controlled trials should be required; and 2) to develop standards for the protection of human subjects who participate in such studies. Conference participants developed consensus on 16 statements regarding DBS as an experimental treatment for severe psychiatric illness. The meeting was recorded and transcribed, a manuscript drafted, and all participants were given the opportunity to contribute to several rounds of revision. The consensus items are given below, accompanied by brief summaries of the presentations and discussions that led to their formulation.
Conference participants recognize that the implementation of these guidelines will require a commitment from clinicians, investigators, institutions, industry, funders and government regulatory agencies. Several recommendations involve a substantial burden of long-term monitoring and financial support to protect the safety and rights of research subjects. However, following these guidelines has the potential to benefit research subjects, their social supports, future patients, clinical investigators, and device manufacturers, by ensuring that this promising technology is studied in carefully defined settings where it is more likely to offer benefit and less likely to harm.
Participants in the meeting reported here included: Brian S. Appleby, M.D.; Carolyn Asbury, Sc.M.P.H., Ph.D.; Debra Babcock, Ph.D., M.D.; Hilary Bok, Ph.D.; Jason Brandt, Ph.D.; Mahlon R. DeLong, M.D.; Laura B. Dunn, M.D.; Ruth R. Faden, Ph.D., M.P.H.; Loes Gabriëls, M.D., Ph.D., Msc.Eng.; Benjamin D. Greenberg, M.D., Ph.D.; Suzanne N. Haber, Ph.D.; Mi Hillefors, M.D., Ph.D.; Paul E. Holtzheimer III, M.D.; Kiran K. Khaira, M.A.; Debra J. H. Mathews, Ph.D., M.A.; Zoltan Mari, MD; Helen S. Mayberg, M.D.; Evelyn McCann; Guy M. McKhann, M.D.; Sallie P. Mink, R.N., B.S.; Peter Rabins, M.D., M.P.H.; Steven Rasmussen, M.D., M.M.S.; Alan Regenberg, M.Be.; Matthew V. Rudorfer, M.D.; Thomas E. Schlaepfer, M.D.; Elliot Valenstein, Ph.D., M.A.; Dorothy E. Vawter, Ph.D.; Jerrold L. Vitek, M.D., Ph.D.; John Walkup, M.D. Carol Hart, PhD, wrote the initial draft of the manuscript.
Helen Mayberg is a consultant to ANS, Inc. (Advanced Neuromodulation Systems) and has licensing of intellectual property to ANS. Loes Gabriels has a consultancy agreement with Medtronic (since 2007).
Funding: The conference reported in the manuscript was supported by grant #1R13MH81769-1 from the National Institute of Mental Health and the National Institute of Neurological Disorders and Stroke, and an award from the Dana Foundation.
All other authors report no conflicts of interest or financial disclosures.