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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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Y-BOCS minimum score of 28;

Y-BOCS minimum score of 28

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up[time frame: month 18]

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ [time frame: month 18]

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

0 / 8Eligibility criteria met

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