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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

No Placebo-Only Group

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and do not plan to become pregnant in the next 2 years.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 18 for reporting.

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

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 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

0 / 14Eligibility criteria met