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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
Must not have
Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months
Inability or refusal to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant and do not plan to become pregnant in the next 2 years.
Select...
I am unable or unwilling to give my consent for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hypomania
Percent of subjects that display biomarkers of OCD-related distress
Secondary study objectives
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?
Carnegie Mellon UniversityOTHER
77 Previous Clinical Trials
539,907 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
17 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
1,021 Previous Clinical Trials
6,031,519 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
767 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,368 Previous Clinical Trials
652,250 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,005 Patients Enrolled for Obsessive-Compulsive Disorder
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