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)
1 other identifier
interventional
10
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 21, 2022
CompletedStudy Start
First participant enrolled
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedJanuary 7, 2026
January 1, 2026
2.9 years
October 14, 2022
January 6, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Primary Feasibility Endpoint #1 - OCD Relevant Network
Percentage of patients in which an OCD relevant network can be identified
14 days
Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms
Percentage of patients in which we can identify a stimulation target that acutely improves OCD symptoms during SEEG Stage 1
14 days
Primary Feasibility Endpoint #3 - Willingness to Continue with DBS Stage 2
Percentage of patients willing and able to continue with the DBS Stage 2 after completing the SEEG Stage 1
Day 14
Primary Feasibility Endpoint #4 - Acute Symptomatic Improvement
Percentage of implanted DBS sites associated with both acute symptomatic improvement during the SEEG Stage 1 and therapeutic benefit during the DBS Stage 2.
Approximately 60 weeks
Primary Efficacy Endpoint - Treatment Response
Treatment response, determined by the difference in Y-BOCS II score between the active stimulation (ON) condition and sham control (OFF) condition
Up to 24 weeks
Primary Safety Endpoint - Serious Adverse Events
Number and type of serious adverse events in this SEEG-guided 4-lead DBS approach compared to conventional DBS for OCD.
Approximately 4 years
Study Arms (2)
SEEG Guided DBS ON-OFF (Stimulation-Sham)
EXPERIMENTALPatients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period.
SEEG Guided DBS OFF-ON (Sham-Stimulation)
SHAM COMPARATORPatients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.
Interventions
For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.
For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase.
Eligibility Criteria
You may qualify if:
- ≥ 22 years and ≤ 75 years of age, at the time of screening
- 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)
- Presence of obsessions, compulsions, or both
- 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
- 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
- Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5
- Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment
- 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
- 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
- Adequate trial of ≥ 1 augmentation trial using an antipsychotic medication
- Adequate trial of clomipramine, either as monotherapy or as an augmentation therapy, unless medically contradicted
- Adequate trials of cognitive behavior therapy-based Exposure and Response Prevention (ERP)
- Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least 8 weeks prior to study enrollment and for the duration of the trial, as determined by the research/study psychiatrist and the PI
- Willingness and ability to discontinue any psychotherapeutic behavioral intervention therapy (e.g. CBT) until the maintenance stage, if any, as determined safe by the research/study psychiatrist
- Study participation in the prospective subject's best psychiatric interest, as determined by the research/study psychiatrist and based on a comprehensive assessment that includes the following: (a) detailed psychiatric history; (b) examination of the mental status; (c) review of psychiatric assessment measures obtained to determine eligibility, as applicable; (d) review of previous medical records for a minimum of 2 years prior to enrollment, or as applicable; and (e) consideration of the potential benefits versus risks of study participation
- +8 more criteria
You may not qualify if:
- 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 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
- Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
- Lifetime diagnosis of Bipolar I Disorder or Bipolar II Disorder
- 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.
- 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.
- 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 \> 5 minutes
- A residual effect(s) that failed to resolve completely at least 1 year prior to the date of screening
- An abnormality on a neuroimaging study (MRI, CT Scan) that was/is attributable to the head trauma
- \> 1 head injury within the past 2 years which were diagnosed as a concussion, concussive-type or traumatic brain injury (TBI), according to medical records or as reported by the prospective subject or a family member
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Casey H. Halpern, M.D.lead
- Stanford Universitycollaborator
Study Sites (2)
Stanford University
Stanford, California, 94304, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Neurosurgery, Director of Stereotactic and Functional Neurosurgery
Study Record Dates
First Submitted
October 14, 2022
First Posted
November 21, 2022
Study Start
April 13, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP