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Device

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A
Recruiting
Research Sponsored by Casey H. Halpern, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 22 years and ≤ 65 years of age, at the time of screening
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Study Summary

This trial will study a new type of brain stimulation to treat OCD that hasn't responded to other treatments. It involves 3 stages: mapping, surgery, & randomized trial before open label use.

Who is the study for?
This trial is for adults aged 22-65 with severe, treatment-resistant Obsessive-Compulsive Disorder (OCD), having tried multiple medications and cognitive therapy without success. Participants must be able to follow the study's procedures in English, live within a 6-hour drive of the study sites, have stable housing and support, and commit to no psychotherapy or medication changes during the trial.Check my eligibility
What is being tested?
The trial tests SEEG-guided Deep Brain Stimulation (DBS) using Vercise Genus™ System on those with severe OCD. It involves brain mapping, DBS surgery, parameter optimization, randomized crossover treatment phases followed by open label stimulation over approximately an 18-month period.See study design
What are the potential side effects?
Potential side effects may include discomfort at implantation sites, headache or dizziness post-surgery; risk of infection; possible changes in mood or behavior; unintended movements; speech disturbances; sensory issues like tingling or numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 65 years old.
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I have tried at least two SSRIs for OCD at the highest dose I can tolerate.
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I have tried at least one antipsychotic medication to improve my condition.
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I have tried clomipramine alone or with other treatments, unless it was unsafe for me.
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I have completed enough sessions of ERP therapy.
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I am willing to stop my therapy sessions if the study's psychiatrist agrees.
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I agree to let my doctors and the research team share information about my care.
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I am between 22 and 65 years old.
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I experience obsessions or compulsions.
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My obsessive-compulsive symptoms are not due to drugs or another health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint - Treatment Response
Primary Feasibility Endpoint #1 - OCD Relevant Network
Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SEEG Guided DBS ON-OFF (Stimulation-Sham)Experimental Treatment2 Interventions
Patients 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.
Group II: SEEG Guided DBS OFF-ON (Sham-Stimulation)Placebo Group2 Interventions
Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,358 Previous Clinical Trials
17,320,207 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
1,428 Patients Enrolled for Obsessive-Compulsive Disorder
Casey H. Halpern, M.D.Lead Sponsor
University of California, San FranciscoOTHER
2,482 Previous Clinical Trials
12,164,314 Total Patients Enrolled

Media Library

PMT Stereoencephalography (SEEG) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05623306 — N/A
Obsessive-Compulsive Disorder Research Study Groups: SEEG Guided DBS ON-OFF (Stimulation-Sham), SEEG Guided DBS OFF-ON (Sham-Stimulation)
Obsessive-Compulsive Disorder Clinical Trial 2023: PMT Stereoencephalography (SEEG) Highlights & Side Effects. Trial Name: NCT05623306 — N/A
PMT Stereoencephalography (SEEG) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623306 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 40 or above eligible for this trial?

"The requirement for candidacy in this scientific investigation is to be between 22 and 65 years old."

Answered by AI

Who is eligible to join this clinical trial?

"This clinical trial is welcoming 10 participants that suffer from obsessive-compulsive disorder and are between 22 to 65 years of age."

Answered by AI

Are researchers still enrolling participants for this clinical trial?

"Data posted on clinicaltrials.gov suggests that this medical study is no longer recruiting patients, with the initial posting date being December 1st 2022 and the last update occuring November 14th 2022. However, as of now there are 114 different studies actively accepting participants."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Mar 2025