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Procedure

Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A
Waitlist Available
Led By Wayne Goodman, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed or could not tolerate an adequate trial of clomipramine
Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights

Study Summary

This trial is for participants that have been diagnosed with intractable Obsessive-compulsive disorder (OCD) and want to develop an adaptive Deep Brain Stimulation (aDBS) system.

Who is the study for?
This trial is for adults aged 21-70 with severe OCD that hasn't improved after trying many treatments, including cognitive-behavioral therapy and various medications. Participants must have a history of at least five years of difficult-to-treat OCD and significant distress or impairment due to the disorder.Check my eligibility
What is being tested?
The study tests an adaptive Deep Brain Stimulation (aDBS) system using the Summit RC+S System with ECoG paddles in subjects with hard-to-control OCD. The goal is to improve brain targeting for DBS and find a more effective treatment method for OCD.See study design
What are the potential side effects?
Potential side effects may include discomfort from surgery, infection risk, headache, bleeding in the brain, changes in mood or behavior, seizures, hardware complications like lead movement or device malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried clomipramine for my condition but it didn't work or caused side effects.
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I've tried and didn't respond to certain medications with added antipsychotics.
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I have had OCD for over 5 years that hasn't improved with treatment and significantly affects my daily life.
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I have completed 25 hours of a specific therapy for OCD without success.
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I have tried and not responded to specific antipsychotic drugs.
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My OCD is severe, with a Y-BOCS score of at least 28.
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I have had OCD for over 5 years that hasn't improved with treatment and significantly affects my daily life.
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I am between 21 and 70 years old.
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I have completed 25 hours of a specific therapy for OCD without success.
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I am between 21 and 70 years old.
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My OCD is severe, with a Y-BOCS score of 28 or more.
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I have tried at least three different SSRIs without success.
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My mental health medication has been stable for the last month.

Timeline

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
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Summit RC+S DBS Implant for OCDExperimental Treatment1 Intervention
All subjects will receive surgical implantation of RC+S DBS system with ECoG paddles
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 Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,306 Total Patients Enrolled
5 Trials studying Obsessive-Compulsive Disorder
72 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
997 Previous Clinical Trials
6,002,014 Total Patients Enrolled
14 Trials studying Obsessive-Compulsive Disorder
757 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,712 Previous Clinical Trials
16,346,406 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
149 Patients Enrolled for Obsessive-Compulsive Disorder

Frequently Asked Questions

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

Are there any open slots left for participants in this trial?

"Per the information hosted on clinicaltrials.gov, this trial is not presently seeking new participants. The study was initially posted on July 1st 2021 and last modified on September 12th 2022. Although it does not appear that this particular medical research project requires more patients, there are nearly a thousand other trials actively enrolling at present."

Answered by AI

To what demographic does this medical experiment cater?

"This clinical trial is recruiting five individuals, aged 18 to 70, with a documented history of Obsessive-Compulsive Disorder (OCD). Participants must have unsuccessfully trialled augmentation therapy featuring one of the following antipsychotics: Haloperidol; Risperidone; Quetiapine; Ziprasidone or Aripiprazole. Additionally, they should have been exposed to at least 25 hours of Exposure and Response Prevention (ERP) Therapy by an accredited therapist but still struggle to manage their OCD symptoms which cause significant distress or impairment in daily life. The participants' diagnoses are verified through scoring 28"

Answered by AI

Is this medical trial open to participants aged eighty or below?

"This clinical trial adheres to the following age parameters: 18 is the minimum entry requirement while 70 marks the upper limit."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Tennessee
How old are they?
18 - 65
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
~0 spots leftby Jun 2024