Current Projects
Completed Projects
Further Information
Project Co-ordinator: Dr. phil. Thorsten Galert, M.A. // Contact: Priv.-Doz. Dr. med. Felix Thiele, M.Sc.
J. J. Fins et al.: Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder. Health Affairs, February 2011, vol. 30 no. 2, 302–311
J. J. Finset al.: Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation, Journal of Neural Engineering 2011 May 10; 8(3): 033001
Letters/responses: FDA and Medtronic on Health Affairs article
Workshop Deep Brain Stimulation Program 20./21. January 2011
Duration: 10/08–12/11
Funding: VolkswagenStiftung, Hanover
Deep Brain Stimulation in Psychiatry. Guidance for Responsible Research and Application
In recent years, Deep Brain Stimulation (DBS) has been studied in the treatment of different kinds of psychiatric disorders. Efficacy data are still uncertain, but initial results are promising. However, attempts to use DBS in psychiatry are subject to a high degree of scrutiny because they are seen by critics an unwelcome resurgence of psychosurgery. Although some of these fears may clearly be dispelled since they pertain to obsolete neurosurgical methods, there are other concerns related to the use of DBS in psychiatry deserving of careful consideration.
The aim of this project was to examine in which way recognized standards of research and practice in psychiatry need to be modified in order to account for the special requirements of DBS. Issues of particular interest included the selection of research subjects and patients, the requirements to be met by investigational protocols, the process of obtaining informed consent in clinical research and practice, the safeguarding of patients’ autonomy, and the assessment of long-term side-effects.
The project group is composed of leading international experts from the relevant clinical disciplines neurosurgery, psychiatry, neurology and neuropsychology as well as experts in medical law and ethics. Their goal is to reach a consensus on the required ethical and methodological standards and, thus, to give guidance for responsible research and application of DBS in psychiatry.
Project Group
Professor Dr. med. Thomas E. Schläpfer, Bonn (Chair)
Professor Joseph J. Fins, M.D., F.A.C.P., Ithaca/NY
Cynthia S. Kubu, Ph.D., M.A., Cleveland/OH
Professor Helen S. Mayberg, M.D., F.R.C.P.C., Atlanta/GA
Professor Dr. jur. Reinhard Merkel, Hamburg
Professor Bart Nuttin, M.D., Ph.D., Leuven
Professor Dr. med. Volker Sturm, Köln
Project Co-ordinator: Dr. phil. Thorsten Galert, M.A.
Tel./e-mail: +49 (0) 2641 973-307 • thorsten.galert
ea-aw.de


