Personalized DBS for OCD Guided by Stereoencephalography Mapping (NCT06347978)
A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder (SEEG-Guided DBS for OCD)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (32 items).
Location: University of California, San Francisco — San Francisco, California
Age range: 22 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Diagnosed, according to the Mini International Neuropsychiatric Interview (MINI), as suffering from any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder
- In the opinion of the Principal Investigator and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder
- Present clinical secondary diagnosis of any of the following, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
- Bipolar I Disorder or Bipolar II Disorder
- Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder
- Psychotic Disorder or Mood Disorder with psychotic features
- Current suicidal risk, as determined by the research/study psychiatrist using the brief mental status exam and the psychiatric interview (including the Columbia Suicide Severity Rating Scale \[C-SSRS\]), or significant suicide risk, defined as Hamilton Depression Rating Scale (HDRS-21) Item 3 score of ≥ 3 or any lifetime history of suicide attempt a. Subjects who answer 'Yes' to questions 3, 4, or 5 of the C-SSRS will be excluded and brought by study staff to the nearest emergency room for additional evaluation and psychiatric care.
- Treatment, within 24 months of screening, for any of the following: dependency on, addiction to, use of, abuse of, or overuse of any illicit substance(s), including alcohol, but not including nicotine or caffeine
- History of head trauma associated with any of the following:
- Loss of consciousness for \> 5 minutes
- A residual effect(s) that failed to resolve completely at least 1 year prior to the date of screening
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of California, San Francisco — San Francisco, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Obsessive-Compulsive Disorder
- Towards Remission and Full Recovery From Obsessive-compulsive Disorder — Montreal, Quebec
- Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD — New Haven, Connecticut
- Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD — Toronto, Ontario
- Study of Dextromethorphan in OCD and Related Disorders — Stanford, California
- Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2) — Stanford, California
- Effects of Psilocybin in Obsessive Compulsive Disorder — Baltimore, Maryland
Explore by condition: All Obsessive-Compulsive Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.