SEEG-Guided DBS for OCD
Eligible age
22–75 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Casey H. Halpern, M.D.
You may qualify if…
- ✓ 1. ≥ 22 years and ≤ 75 years of age, at the time of screening
- ✓ 2. Chronic (\> five years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
- ✓ 1. Presence of obsessions, compulsions, or both
- ✓ 2. Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning
- ✓ 3. Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition
- ✓ 4. Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5
- ✓ 3. Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment
- ✓ 4. Lack of adequate response to a history of the following treatments, based on information from any of the following: (a) the current treating physician and/or psychologist; (b) medical records or other forms of communication from previous healthcare providers; and (c) pharmacy records, as determined by the PI
You may not qualify if…
- ✕ 1. 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.
- ✕ 2. 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
- ✕ 3. 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.
- ✕ 4. Acute suicide risk considered significant by any of the following criteria:
- ✕ 1. High suicide risk, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) along with clinician assessment; or
Where it's recruiting
Stanford
Philadelphia
Source: ClinicalTrials.gov · NCT05623306 · last updated 2026-05-14