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Deep Brain Stimulation for Obsessive-Compulsive Disorder

Brown University, Providence, RI
One Month Blinded Discontinuation Period +1 moreN/AWaitlist AvailableLed by Wayne Goodman, MDResearch Sponsored by Baylor College of Medicine

Study Summary

This trial is for people with OCD who have not responded to other treatments. The goal is to use signals from the brain to automatically adjust the Deep Brain Stimulation (DBS) stimulation factors to improve symptom management and reduce stimulation-induced behavioral side effects.

Eligible Conditions
  • Obsessive-Compulsive Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
People who can participate in the study for OCD deep brain stimulation (DBS) must meet the following requirements:
You have been experiencing severe, treatment-resistant OCD for at least five years, which greatly impacts your daily life and causes significant distress.
Your score on the Y-BOCS test must be at least 28.
You have already tried clomipramine and it didn't work for you.
You have already tried a type of therapy called CBT for OCD, where you worked with a therapist for at least 25 hours on exposure and response prevention.
I'm sorry, but the provided criterion seems to be incomplete. Could you please provide more details or clarify the inclusion criteria for implanted ET subjects?
You have a long-term diagnosis of Essential Tremor, except if it affects only your head, and you have a deep brain stimulation (DBS) implant.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of subjects that display biomarkers of DBS-induced hypomania
Percent of subjects that display biomarkers of OCD-related distress
Secondary outcome measures
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: One Month Blinded Discontinuation PeriodExperimental Treatment1 Intervention
all subjects will enter a one-month blinded discontinuation period to confirm clinical benefit at the end of Month 8.
Group II: Activa PC+S DBS implant for OCDExperimental Treatment1 Intervention
all subjects will receive surgical implantation of DBS system

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,316 Previous Clinical Trials
644,179 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,008 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
444 Previous Clinical Trials
525,881 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
467 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,685 Previous Clinical Trials
16,303,896 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
152 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Activa PC+S DBS implant for OCD (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03457675 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Activa PC+S DBS implant for OCD, One Month Blinded Discontinuation Period
Obsessive-Compulsive Disorder Clinical Trial 2023: Activa PC+S DBS implant for OCD Highlights & Side Effects. Trial Name: NCT03457675 — N/A
Activa PC+S DBS implant for OCD (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03457675 — N/A

Frequently Asked Questions

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

To what extent is this trial open to participants?

"This research project is only available to people between 21 and 70 who have been diagnosed with obsessive-compulsive disorder. The clinical trial will accept up to two participants for the study."

Answered by AI

Are there any openings left in this clinical research project?

"The information listed on clinicaltrials.gov attests that this medical trial is not presently recruiting patients. Initially advertised in July 2018, it was last updated a few months ago in February 2022. Despite the cessation of patient recruitment for this particular study, there are 114 other trials actively enrolling participants at present."

Answered by AI

Is this study inclusive of geriatric participants?

"As per the stipulations of this trial, prospective enrollees should be within the age range of 21 to 70. 23 trials are available for younger patients while 67 studies are open to those over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
University of Pittsburgh
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I have harm ocd which is very lonely I can’t really talk to anyone about except a therapist.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

I’d like to know how many treatments?
PatientReceived 2+ prior treatments
~0 spots leftby Jun 2024