Deep Brain Stimulation for Disorders of Mood Thought and Behavior: Scientific an

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): In the last decade, the treatment of Parkinson disease and other movement disorders has been revolutionized by the advent of deep brain stimulation (DBS), a procedure in which electrodes are implanted into the brain and a constant electrical current is applied via a pulse generator implanted in the chest. In addition to alleviation of motor symptoms, DBS has been known to produce psychiatric effects, including transient depression, mania, and alleviation of obsessive- compulsive symptoms. In part due to these observed effects, in concert with the lack of other effective treatments, DBS has been proposed as a therapy for treatment-resistant depression (TRD), obsessive-compulsive disorder (OCD) and Tourette syndrome. Preliminary reports have suggested that DBS may be effective for such disorders, and there are currently several research teams exploring DBS for the treatment of disorders of mood, thought and behavior. We propose to convene a small professional conference to explore scientific and ethical issues related to the design and conduct of clinical trials of DBS for disorders of mood, thought and behavior, while such research is still in its formative stages. The specific aims of this meeting are: 1. To explore the extent to which the use of DBS for the treatment of disorders of mood, thought and behavior is similar to and different from pharmacological treatment for such disorders, and if different, what ethical challenges are unique to DBS in this context; 2. To establish consensus among researchers about the design of clinical trials of DBS for disorders of mood, thought and behavior, including inclusion/exclusion criteria and whether randomized, controlled trials should be required; 3. To develop standards for the protection of human subjects who participate in such studies, given their potentially diminished capacity to provide valid informed consent. DEEP BRAIN STIMULATION FOR DISORDERS OF MOOD, THOUGHT AND BEHAVIOR: SCIENTIFIC AND ETHICAL ISSUES This project is designed to foster and facilitate discussions and deliberations of the scientific and ethical issues raised by the use of deep brain stimulation for disorders of mood, thought and behavior early in the development of the science. Such a proactive approach to emerging treatments and technologies benefits the public by forestalling potential ethical problems related to, for example, informed consent, inclusion/exclusion criteria and privacy. [unreadable] [unreadable] [unreadable]