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Neurostimulation

Deep Brain Stimulation for Obsessive-Compulsive Disorder

Q: Are there any facilities in the US currently undertaking this research program?

<p>The Cleveland Clinic in <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>, George <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> University Hospital in the District of Columbia and Butler Hospital in <a href="https://www.withpower.com/clinical-trials/rhode-island">Rhode island</a> are <a href="https://www.withpower.com/clinical-trials/all">all</a> partaking as trial sites for this clinical study. Additionally, 9 other locations throughout the United States are being utilised to enroll patients.</p>

Phase 4

Waitlist Available

Led By Benjamin D. Greenberg, MD, PhD

Research Sponsored by Butler Hospital

Eligibility Criteria Checklist

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

Must have

Documented highly treatment refractory illness with persistence of severe symptoms and impairment for 5 or more years despite specific treatment criteria

Either drug free or on a stable drug regimen for at least 6 weeks before study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up gaf score observed means at month-12

Awards & highlights

Study Summary

This trial will test if deep brain stimulation is a safe and effective treatment for people with severe obsessive-compulsive disorder who haven't responded to other treatments.

Who is the study for?

This trial is for adults with severe Obsessive-Compulsive Disorder (OCD) that hasn't improved after trying many treatments, including various medications and therapy. Participants should be in good health overall, have a Yale-Brown OCD Scale score of at least 30, and function poorly in daily life. They can't join if they have psychotic disorders, low IQ, significant cognitive impairments, substance abuse issues, high suicide risk or certain medical conditions.Check my eligibility

What is being tested?

The study tests deep brain stimulation (DBS), where electrodes are implanted to send electrical impulses to specific brain areas. There's an active DBS group getting real treatment and a sham DBS group receiving fake treatment as a comparison. The goal is to see if active DBS safely reduces OCD symptoms better than the sham procedure.See study design

What are the potential side effects?

Potential side effects from DBS may include headache, infection at the surgery site, confusion or difficulty concentrating shortly after the operation. Long-term risks might involve changes in mood or behavior but vary widely between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My illness has been severe and unresponsive to treatment for 5+ years.

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I have not changed my medications in the last 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ gaf score observed means at month-12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~gaf score observed means at month-12

This trial's timeline: 3 weeks for screening, Varies for treatment, and gaf score observed means at month-12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global Assessment of Functioning Scale (GAF)

Social and Occupational Functioning Assessment Scale (SOFAS)

Yale-Brown Obsessive-Compulsive Scale (YBOCS Severity Ratings)

Secondary outcome measures

Behavioral Activation for Depression Scale (BADS)

Hamilton Anxiety Rating Scale (HARS)

Hamilton Depression Rating Scale (HDRS)

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active DBSActive Control1 Intervention

Participants will receive deep brain stimulation.

Group II: Sham DBSPlacebo Group2 Interventions

Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor

129 Previous Clinical Trials

16,391 Total Patients Enrolled

12 Trials studying Obsessive-Compulsive Disorder

420 Patients Enrolled for Obsessive-Compulsive Disorder

National Institute of Mental Health (NIMH)NIH

2,782 Previous Clinical Trials

2,689,080 Total Patients Enrolled

65 Trials studying Obsessive-Compulsive Disorder

13,954 Patients Enrolled for Obsessive-Compulsive Disorder

Benjamin D. Greenberg, MD, PhDPrincipal InvestigatorButler Hospital/Brown University

Media Library

Active DBS (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT00640133 — Phase 4

Obsessive-Compulsive Disorder Research Study Groups: Active DBS, Sham DBS

Obsessive-Compulsive Disorder Clinical Trial 2023: Active DBS Highlights & Side Effects. Trial Name: NCT00640133 — Phase 4

Active DBS (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00640133 — Phase 4

Frequently Asked Questions

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

Has the FDA given its stamp of approval to Active DBS?

"The overall safety of active DBS has been evaluated as a 3 on our scale, since this phase 4 trial already received approval."

Answered by AI

To what extent will the results of this trial have an impact?

"The primary endpoint of this trial, to be assessed at 12 months using the GAF score is the Yale-Brown Obsessive-Compulsive Scale (YBOCS Severity Ratings). Secondary endpoints involve Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), Montgomery-Asberg Depression Rating Scale (MADRS) interviewer administered measure assessing depression symptoms, and Hamilton Depression Rating Scale (HDRS) only administered at baseline and month 3."

Answered by AI

Are there vacancies available for trial participants?

"Per the records on clinicaltrials.gov, this particular medical experiment is not currently enrolling patients. Initially posted on March 1st 2008 and last edited on May 6th 2022, it does not presently have any openings for volunteers; however, 114 other studies are actively recruiting participants at present."

Answered by AI

Is there an age limit for enrolment in this clinical research project?

"This medical study seeks participants who are aged 18 or above and younger than 75."

Answered by AI

Are there any facilities in the US currently undertaking this research program?

"The Cleveland Clinic in Ohio, George Washington University Hospital in the District of Columbia and Butler Hospital in Rhode island are all partaking as trial sites for this clinical study. Additionally, 9 other locations throughout the United States are being utilised to enroll patients."

Answered by AI

Who meets the criteria for participation in this experiment?

"This clinical trial is currently seeking 27 participants between 18 and 75 years of age with a documented history of Obsessive-Compulsive Disorder (OCD). To be eligible, individuals must exhibit disabling severity on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score at least 30, have undertaken three trials of or demonstrated intolerance to serotonin transporter inhibitors such as fluoxetine and sertraline for 3 months at maximum dosage levels including clomipramine either singularly or in combination; demonstrate impaired functioning with a Global Assessment Functioning Score below 45; received adequate behavior therapy from an OCD specialist consisting of"

Answered by AI