Actively Recruiting
SEEG-Guided DBS for OCD
Led by Casey H. Halpern, M.D. · Updated on 2026-05-14
12
Participants Needed
2
Research Sites
363 weeks
Total Duration
On this page
Sponsors
C
Casey H. Halpern, M.D.
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SEEG-Guided DBS for OCD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 75 years at screening
- Chronic OCD diagnosed by DSM-5 criteria for more than five years
- Presence of obsessions, compulsions, or both causing significant distress or impairment
- OCD symptoms not caused by substances or other medical conditions
- Severe OCD symptoms with Y-BOCS I score of 28 or higher within two weeks before enrollment
- Inadequate response to at least two SSRIs, one antipsychotic augmentation, clomipramine, and cognitive behavior therapy-based Exposure and Response Prevention
- Ability and willingness to keep psychotropic medication doses stable for at least eight weeks before and during the trial
- Willingness to discontinue or not start new ERP therapy until maintenance stage if applicable
- Psychiatric assessment supports study participation in the participant's best interest
- Agreement to regular evaluations by a licensed psychiatrist or psychologist during the study
- Living within six hours' drive of study sites with no plans to relocate during the study
- Adequate social support and emergency contacts
- Ability to understand instructions and complete assessments in English
- Willingness to comply with study procedures and provide informed consent
- Permission to share medical information between research and treating clinicians
You will not qualify if you...
- Primary psychiatric diagnoses other than OCD, including Hoarding Disorder
- Severe personality disorders or hospitalization for Borderline Personality Disorder
- Bipolar I or II disorder, current eating disorders active within five years, primary psychotic disorders, or mood disorders with psychotic features active within two years
- Significant acute suicide risk or suicide attempt requiring hospitalization within past year
- Substance dependency or abuse within two years, excluding nicotine or caffeine
- History of significant head trauma with prolonged loss of consciousness or residual effects
- Presence of cardiac, brain, or implanted medical pumps
- Need for diathermy treatments
- Hearing loss affecting study compliance
- Metal or metallic particles in the head (except inside the mouth)
- Pregnancy during screening or study period
- History of involuntary movements
- Excessive or prolonged bleeding or abnormal blood clotting parameters
- Allergy to gadolinium
- Inability to safely undergo MRI or CT scan
- Any medical condition hindering study compliance or data integrity
- Current participation in other conflicting research studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Stanford University
Stanford, California, United States, 94304
Active, Not Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
Research Team
N
Neurosurgery Clinical Research Divison
CONTACT
M
Marie Kerr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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