SEEG-Guided DBS for OCD (NCT05623306)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (31 items).
Location: Stanford University — Stanford, 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:
- Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder. a. Subjects with secondary psychiatric diagnosis will not be excluded, except as described below.
- In the opinion of the PI 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
- Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation: a. Lifetime diagnosis of Bipolar I Disorder or Bipolar II Disorder b. Current/active diagnosis of Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder i. Diagnosis will be considered current/active if the subject had an active episode within five years of screening. c. Lifetime diagnosis of a primary psychotic disorder (e.g. Schizophrenia, Schizoaffective Disorder) d. Current/active diagnosis of mood disorder with psychotic features i. Diagnosis will be considered current/active if the subject had an active episode within two years of screening.
- Acute suicide risk considered significant by any of the following criteria:
- High suicide risk, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) along with clinician assessment; or
- A suicide attempt within the past twelve months that led to hospitalization; or
- Suicide risk that, in the investigator's clinical judgment, necessitates inpatient treatment based on the individual's history and current condition.
- Treatment, within two years 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 \> five minutes
- A residual effect(s) that failed to resolve completely at least one 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 (2 Sites)
- Stanford University — Stanford, California
- University of Pennsylvania — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (215) 829-6720
Email: npn@uphs.upenn.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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Explore by condition: All Obsessive-Compulsive Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.