SEEG-Guided DBS for OCD
NCT05623306 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-05-14
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.
Conditions
- Obsessive-Compulsive Disorder
Interventions
- DEVICE
-
Stereoencephalography (SEEG)
For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.
- DEVICE
-
Deep 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.
Sponsors & Collaborators
- collaborator OTHER
- collaborator OTHER
- collaborator OTHER
-
Boston Scientific Corporation
collaborator INDUSTRY - collaborator INDUSTRY
-
Casey H. Halpern, M.D.
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 22 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-13
- Primary Completion
- 2030-04-01
- Completion
- 2030-04-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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