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Procedure

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
At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
A primary diagnosis of OCD with Y-BOCS minimum score of 28;
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upmonth 18
Awards & highlights
No Placebo-Only Group

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.

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 have been suffering from OCD for at least 5 years and have not responded to previous treatments. The OCD causes significant distress and affects your daily life.
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You have been diagnosed with OCD and your Y-BOCS score is at least 28.
Select...
paliperidone The following antipsychotics can be used to augment one or more of the aforementioned drugs: haloperidol, risperidone, quetiapine, ziprasidone, aripiprazole, paliperidone.
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You have already received cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) with a therapist who has documented a minimum of 25 hours of exposure and response prevention (ERP) treatment.
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You have been struggling with severe OCD for at least five years, and it significantly affects your daily life and well-being.
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You have tried clomipramine before, but it didn't work well for you or you couldn't handle the side effects.
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You have tried a therapy called CBT (cognitive-behavioral therapy) for OCD (obsessive-compulsive disorder), but it didn't work. The therapy included at least 25 hours of documented exposure and response prevention (ERP) with a therapist who specializes in OCD.

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

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

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
599 Previous Clinical Trials
829,244 Total Patients Enrolled
5 Trials studying Obsessive-Compulsive Disorder
72 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
982 Previous Clinical Trials
5,995,989 Total Patients Enrolled
14 Trials studying Obsessive-Compulsive Disorder
994 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,687 Previous Clinical Trials
16,342,205 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
Recent research and studies
clinicaltrials.govStudy
Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder
Wayne Goodman MD 2021. "Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04806516.
All > Obsessive Compulsive Disorder > Ocd
~1 spots leftby Jun 2024
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