Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of DBS for Treatment-Refractory OCD|
- Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey [ Time Frame: Measured pre- and post-intervention ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2001|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Deep Brain Stimulation
Participants receive deep brain stimulation treatment for 30 months.
Procedure: Deep Brain Stimulation
Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.
Despite advances in pharmacological and behavioral therapies for OCD, a substantial number of patients fail to improve significantly following years of conventional and experimental interventions. For some patients, stereotactic neurosurgery is the only promising option available. Although this procedure has relatively few side effects in the majority of OCD patients and may lead to enduring benefits, its effects on brain tissue and function are irreversible. Bilateral deep brain stimulation (DBS) is an adjustable and partially reversible procedure that may be a more effective treatment for patients with OCD. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory OCD.
Participants receive DBS treatment for 30 months. Obsessive Compulsive scales, depression scales, neuropsychological evaluations, and surveys are used to assess participants.
Participants are monitored for 2 years after DBS treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057603
|United States, Florida|
|University of Florida College of Medicine|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Herbert Ward, MD||University of Florida|