Deep Brain Stimulation

Summit RC+S DBS Implant for OCD for Obsessive-Compulsive Disorder

University of Pittsburgh, Pittsburgh, PA
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 a hard-to-control form of OCD. The goal is to find a more reliable system for treating OCD by studying how to best place electrodes in the brain to deliver electrical stimulation.

Eligible Conditions
  • Obsessive-Compulsive Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You need to have a minimum score of 28 on the Y-BOCS assessment.
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Your score on the Y-BOCS test must be at least 28.
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You have been dealing with OCD that has not responded to treatment for at least five years, and it is causing you significant distress and difficulty in your daily life.
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You have already tried CBT therapy for OCD with an expert therapist for at least 25 hours and it did not help.
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Criteria for including subjects in the OCD DBS study:
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You have been struggling with severe OCD for at least five years, and it significantly affects your daily life and causes distress.
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You have already tried clomipramine and it didn't work for you.
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You have already tried a type of therapy called CBT for OCD, where you worked with a specialist for at least 25 hours on exposure and response prevention techniques, but it did not work for you.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame: month 18]
This trial's timeline: 3 weeks for screening, Varies for treatment, and [time frame: 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
Hypomania
Obsessive-Compulsive Personality
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: Summit RC+S DBS Implant for OCDExperimental Treatment1 Intervention
all subjects will receive surgical implantation of DBS system
Group II: One Month Blinded Discontinuation PeriodExperimental Treatment1 Intervention
The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline

Find a site

Who is running the clinical trial?

Carnegie Mellon UniversityOTHER
72 Previous Clinical Trials
538,800 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
19 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,297 Previous Clinical Trials
460,855 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,007 Patients Enrolled for Obsessive-Compulsive Disorder
MedtronicIndustry Sponsor
590 Previous Clinical Trials
820,786 Total Patients Enrolled
5 Trials studying Obsessive-Compulsive Disorder
74 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,664 Previous Clinical Trials
16,297,640 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
151 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
964 Previous Clinical Trials
5,984,662 Total Patients Enrolled
14 Trials studying Obsessive-Compulsive Disorder
996 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
438 Previous Clinical Trials
525,228 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
466 Patients Enrolled for Obsessive-Compulsive Disorder
Wayne Goodman, MDPrincipal Investigator
Baylor College of Medicine
6 Previous Clinical Trials
148 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
148 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Summit RC+S System (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04281134 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Summit RC+S DBS Implant for OCD, One Month Blinded Discontinuation Period
Obsessive-Compulsive Disorder Clinical Trial 2023: Summit RC+S System Highlights & Side Effects. Trial Name: NCT04281134 — N/A
Summit RC+S System (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04281134 — N/A

Frequently Asked Questions

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

Are there any restrictions on who can participate in this research project?

"This clinical trial is admitting a maximum of three individuals aged between twenty-one and seventy, suffering from Obsessive Compulsive Disorder. Criteria for admission includes being male or female; having experienced OCD symptoms which cause significant distress and impairment to their life for at least five years; a minimum score of 28 on the Yale–Brown Obsessive Compulsive Scale (Y-BOCS); failed augmentation therapy with one of six antipsychotics; inadequate response to Cognitive Behavioral Therapy consisting 25 hours of Exposure Response Prevention provided by an expert therapist."

Answered by AI

Is this medical study open to individuals aged 45 and above?

"The requirements for this clinical trial stipulate that patients must be between 21 and 70 years old. There are 23 studies specifically tailored towards minors while 67 are geared to elderly individuals."

Answered by AI

Is there an open enrollment period for this clinical experiment?

"According to the information presented on clinicaltrials.gov, this medical study is not presently recruiting patients. Initially posted in October 2019 and last updated February 2022, there are 114 alternative trials enrolling individuals at present."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
California
~0 spots leftby Jun 2024