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SEEG-Guided DBS for OCD | Clinical Trials | Clareo Health

RECRUITINGNA

SEEG-Guided DBS for OCD

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)

NCT05623306•Casey H. Halpern, M.D.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

22 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥ 22 years and ≤ 75 years of age, at the time of screening
•2. Chronic (\> 5 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 Principal Investigator
•1. Adequate trial of ≥ 2 selective serotonin reuptake inhibitors (SSRIs) for an adequate duration at the maximum dose recommended for OCD or at the maximally-tolerated dose according to the FDA-approved package labeling
•2. Adequate trial of ≥ 1 augmentation trial using an antipsychotic medication
+13 more criteria

Exclusion Criteria

•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 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
•3. Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
•1. Lifetime diagnosis of Bipolar I Disorder or Bipolar II Disorder
•2. 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 5 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 2 years of screening.
•4. 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.
•5. 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
+23 more criteria

Locations (2)

Stanford University

Stanford, California, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 13, 2023

Primary Completion Date

March 1, 2026

Completion Date

January 1, 2027

Last Updated

January 7, 2026

Enrollment

ESTIMATED participants

Conditions

Obsessive-Compulsive Disorder

Interventions

PMT Stereoencephalography (SEEG)

DEVICE

Vercise Genus™ Deep Brain Stimulation (DBS) System or Percept™ PC Neurostimulation System

DEVICE

Contacts

Giovanna Rocchio

CONTACT

215-829-6720 Giovanna.Rocchio@Pennmedicine.upenn.edu

Disha Joshi Regulatory Specialist

CONTACT

215-829-6720 disha.joshi@pennmedicine.upenn.edu

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Obsessive-Compulsive Disorder (OCD)

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Treatment Resistant DepressionMajor Depressive Episode+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SEEG-Guided DBS for OCD

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Exclusion Criteria

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