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Procedure

DBS Therapy for Obsessive-Compulsive Disorder (DBS Trial)

N/A
Recruiting
Led By Albert J Fenoy, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
have a diagnosis of OCD with a documented duration of at least 5 years
have failed to improve following treatment with at least 3 selective serotonin reuptake inhibitors (SSRIs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

DBS Trial Summary

This trial is ongoing, with long-term follow-up of 12-60 months.

Who is the study for?
This trial is for adults over 18 with severe or extreme OCD lasting at least 5 years, who haven't responded to CBT and at least three SSRIs. Candidates should not have primary hoarding symptoms, previous brain surgery in the target area, neurological disorders like dementia, be pregnant, have bleeding disorders or need routine MRIs.Check my eligibility
What is being tested?
The Reclaim™ DBS Therapy is being tested as an alternative to irreversible neurosurgical procedures for patients with chronic, severe OCD resistant to medication and behavioral therapy. It involves stimulating specific brain regions without destroying tissue.See study design
What are the potential side effects?
While the document doesn't specify side effects of Reclaim™ DBS Therapy directly, similar treatments may cause discomfort at implant site, headache, mood changes, movement issues or changes in thought processes.

DBS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with OCD for 5 years or more.
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I have tried at least 3 SSRIs without improvement.
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I have completed or attempted Cognitive Behavior Therapy.
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I am eligible for a deep brain stimulation device implant.
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I am 18 years old or older.

DBS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary outcome measures
Safety as indicated by the number of Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

DBS Trial Design

1Treatment groups
Experimental Treatment
Group I: Reclaim™ DBS TherapyExperimental Treatment1 Intervention
Procedure: Reclaim™ DBS Therapy The DBS lead is stereotactically introduced into the target in the brain (AIC) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region. This is performed by a neurosurgeon skilled in this technique, as the same procedure is routinely performed in patients with other diseases (using other brain targets).

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
896 Previous Clinical Trials
318,192 Total Patients Enrolled
MedtronicIndustry Sponsor
604 Previous Clinical Trials
828,509 Total Patients Enrolled
5 Trials studying Obsessive-Compulsive Disorder
27 Patients Enrolled for Obsessive-Compulsive Disorder
Albert J Fenoy, MD3.554 ReviewsPrincipal Investigator - UT Health Science Center at Houston
The University of Texas Health Science Center, Houston
2 Previous Clinical Trials
92 Total Patients Enrolled
5Patient Review
I was diagnosed with dystonia in 2021 and prescription medications did not alleviate the symptoms of involuntary eye closing, tremors in my hands and difficulty swallowing. In fact, the symptoms were getting worse over time, especially difficulty in swallowing. My doctors said brain surgery was the next necessary step. In November 2021, I consulted Dr. Albert John Fenoy, and he told me the symptoms I was experiencing could be reduced in severity or eliminated entirely with deep brain stimulation surgery. Two electrodes would be inserted into my brain. Two weeks later a computer and battery are implanted in my chest and wires are run internally up my neck and inside my scalp

Media Library

Reclaim™ DBS Therapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02773082 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Reclaim™ DBS Therapy
Obsessive-Compulsive Disorder Clinical Trial 2023: Reclaim™ DBS Therapy Highlights & Side Effects. Trial Name: NCT02773082 — N/A
Reclaim™ DBS Therapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02773082 — N/A

Frequently Asked Questions

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

What criteria must be met to qualify for participation in this research?

"This clinical trial is open to 50 individuals aged 18-65 with a compulsive personality. To be eligible, they must have had an OCD diagnosis for at least 5 years, their illness should rate as extreme or severe, and there can't be any other serious psychiatric conditions (e.g., comorbid personality disorder) or addiction issues present. Additionally, those who apply need to show evidence of concurrent depression and anxiety."

Answered by AI

How many participants has this medical experiment recruited?

"Affirmative, information provided on clinicaltrials.gov shows that this trial is still open and actively recruiting patients. The experiment was initally posted on August 1st 2021 and the last update occurred February 12th 2021. Currently they need 50 participants from a single site to take part in the study."

Answered by AI

Is the enrollment phase for this study still open to participants?

"Yes, clinicaltrials.gov confirms that this medical study is actively seeking participants. The trial commenced on August 1st 2021 and the last update was posted February 12th of the same year; 50 patients are needed from one location."

Answered by AI

Is this clinical trial open to elderly participants of 75 years and older?

"This clinical trial is open to anyone of legal age (18+) and under 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
UT Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
~33 spots leftby Jan 2030