A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Multi-Lead Deep Brain Stimulation for Treatment-Refractory Obsessive-Compulsive Disorder (SEEG-Guided DBS for OCD)
Casey H. Halpern, M.D.
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
- Age range
- 22–75 years
- Sex
- All
- Healthy volunteers
- No
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 effec…
Interventions
- DeviceStereoencephalography (SEEG)
For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.
- DeviceDeep Brain Stimulation (DBS)
For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase.
Locations (2)
- Stanford UniversityStanford, California
- University of PennsylvaniaPhiladelphia, Pennsylvania