Actively Recruiting
Personalized DBS for OCD Guided by Stereoencephalography Mapping
Led by Andrew Moses Lee, MD, PhD · Updated on 2025-04-22
10
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 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 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.
CONDITIONS
Official Title
Personalized DBS for OCD Guided by Stereoencephalography Mapping
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 75 years at screening
- Chronic OCD diagnosed by DSM-5 with symptoms lasting more than 5 years
- Presence of obsessions and/or compulsions 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
- No adequate response to at least 2 SSRIs, 1 antipsychotic augmentation, clomipramine, and cognitive behavior therapy
- If available, no adequate response to transcranial magnetic stimulation (TMS) treatment
- Willingness to maintain stable psychotropic medication doses for at least 8 weeks before and during the study
- Psychiatric assessment confirming study participation is in participant's best interest
- Agreement to regular psychiatric evaluations every 3 months
- Adequate social support and stable housing
- Ability to provide two emergency contacts and allow their verification
- Ability to understand instructions and complete assessments in English
- Willingness to comply with study procedures and visits
- Consent to communication between research team and treating clinicians
- Ability and willingness to provide informed consent
You will not qualify if you...
- Any other primary psychiatric diagnosis by DSM-5, including Hoarding Disorder
- Severe personality disorders or history of hospitalization for borderline personality disorder
- Secondary diagnosis of Bipolar I or II, eating disorders, psychotic disorders, or mood disorder with psychotic features
- Current or significant suicide risk or any lifetime suicide attempt
- Substance dependency or abuse within 24 months before screening (excluding nicotine or caffeine)
- History of serious head trauma or multiple concussions within 2 years
- Presence of cardiac or brain implants, implanted medical pumps, or similar devices
- Requirement for diathermy treatments
- Hearing loss affecting study participation
- Metal or metallic particles in the head (except inside the mouth)
- Pregnancy during screening or study (3 years)
- Uncontrolled or untreated physical, systemic, or metabolic disorders including hypertension
- History of involuntary movements affecting imaging
- History of excessive or prolonged bleeding or blood clotting abnormalities
- Allergy to gadolinium
- Inability to safely undergo MRI or CT scans
- Any medical condition that may hinder compliance or affect study data
- Participation in other research interfering with this study's objectives or timeline
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
T
Tenzin Norbu, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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