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Peter Rabins, MD, MPH; Brian S. Appleby, MD; Jason Brandt, PhD; Mahlon R. DeLong, MD; Laura B. Dunn, MD; Loes Gabriëls, MD, PhD, MScEng; Benjamin D. Greenberg, MD, PhD; Suzanne N. Haber, PhD; Paul E. Holtzheimer III, MD; Zoltan Mari, MD; Helen S. Mayberg, MD; Evelyn McCann; Sallie P. Mink, RN, BS; Steven Rasmussen, MD, MMS; Thomas E. Schlaepfer, MD; Dorothy E. Vawter, PhD; Jerrold L. Vitek, MD, PhD; John Walkup, MD; Debra J. H. Mathews, PhD, MA

Arch Gen Psychiatry. 2009;66(9):931-937.

Context  A 2-day consensus conference was held to examine scientific and ethical issues in the application of deep brain stimulation for treating mood and behavioral disorders, such as major depression, obsessive-compulsive disorder, and Tourette syndrome.

Objectives  The primary objectives of the conference were to (1) establish consensus among participants about the design of future clinical trials of deep brain stimulation for disorders of mood, behavior, and thought and (2) develop standards for the protection of human subjects participating in such studies.

Results  Conference participants identified 16 key points for guiding research in this growing field.

Conclusions  The adoption of the described guidelines would help to protect the safety and rights of research subjects who participate in clinical trials of deep brain stimulation for disorders of mood, behavior, and thought and have further potential to benefit other stakeholders in the research process, including clinical researchers and device manufactures. That said, the adoption of the guidelines will require broad and substantial commitment from many of these same stakeholders.

Author Affiliations: Departments of Psychiatry and Behavioral Sciences (Drs Rabins, Appleby, Brandt, Schlaepfer, and Walkup and Ms Mink), and Neurology (Dr Mari), Johns Hopkins Hospital, Baltimore, Maryland; Departments of Neurology (Drs DeLong and Mayberg) and Psychiatry and Behavioral Sciences (Drs Holtzheimer and Mayberg), Emory University, Atlanta, Georgia; Department of Psychiatry, University of California–San Francisco, San Francisco (Dr Dunn); University Hospital Gathuisberg of Leuven, Leuven, Belgium (Dr Gabriëls); Warren Alpert Medical School, Brown University, Providence, Rhode Island (Drs Greenberg and Rasmussen); University of Rochester School of Medicine, University of Rochester, Rochester, New York (Dr Haber); Baltimore, Maryland (Ms McCann); University Hospital Bonn, University of Bonn, Bonn, Germany (Dr Schlaepfer); Minnesota Center for Health Care Ethics, Minneapolis, Minnesota (Dr Vawter); Department of Neurosciences, Cleveland Clinic, Cleveland, Ohio (Dr Vitek); and Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland (Dr Mathews).

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