Trial Parameters
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Brief Summary
This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 22 years and ≤ 75 years of age, at the time of screening 2. Chronic (\> five years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5) 1. Presence of obsessions, compulsions, or both 2. Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning 3. Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition 4. Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5 3. Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment 4. Lack of adequate response to a history of the following treatments, based on information from any of the following: (a) the c