SEEG-Guided DBS for OCD

NCT05623306 | Recruiting DMC FDA Device

• 1 other identifier: G220185
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 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.

Conditions

Obsessive-Compulsive Disorder

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)

ON-OFF (Stimulation-Sham)

EXPERIMENTAL

Participants randomized to the ON-OFF arm will receive active stimulation during the randomization phase for up to 12 weeks. The participants will then have their device turned off and receive sham stimulation during the crossover phase for up to 12 weeks.

Device: Stereoencephalography (SEEG); Device: Deep Brain Stimulation (DBS)

OFF-ON (Sham-Stimulation)

SHAM COMPARATOR

Participants randomized to the OFF-ON arm will have their device turned off and receive sham stimulation during the randomization phase for up to 12 weeks. The participants will then receive active stimulation during the crossover phase for up to 12 weeks.

Device: Stereoencephalography (SEEG); Device: Deep Brain Stimulation (DBS)

Interventions

Stereoencephalography (SEEG) DEVICE

For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.

OFF-ON (Sham-Stimulation); ON-OFF (Stimulation-Sham)

Deep Brain Stimulation (DBS) DEVICE

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.

OFF-ON (Sham-Stimulation); ON-OFF (Stimulation-Sham)

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 22 years and ≤ 75 years of age, at the time of screening
• 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)
• 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 PI
• 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 eight 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 or refrain from initiating ERP therapy 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 two years prior to enrollment, or as applicable; and (e) consideration of the potential benefits versus risks of study participation

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 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
• An abnormality on a neuroimaging study (MRI, CT Scan) that was/is attributable to the head trauma

Sponsors & Collaborators

• Casey H. Halpern, M.D.: lead
• Stanford University: collaborator
• University of Pennsylvania: collaborator
• Mayo Clinic: collaborator
• Boston Scientific Corporation: collaborator
• Medtronic: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94304, United States

ACTIVE NOT RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Neurosurgery Clinical Research Divison

CONTACT

215-829-6720; npn@uphs.upenn.edu

Marie Kerr

CONTACT

215-829-6720; marie.kerr@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurosurgery

Model Details: Stage 1: Invasive SEEG Monitoring and Recovery Stage 2: SEEG-Guided DBS Implantation and Optimization of DBS Programming Stage 3: Randomized Sham-Controlled Crossover Trial

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 21, 2022
• Study Start: April 13, 2023
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

US (2)