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Deep Brain Stimulation
Deep Brain Stimulation for Obsessive-Compulsive Disorder (Phase Ib Trial)
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 an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist
Male or female between ages 21 and 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: month 18]
Awards & highlights
Phase Ib Trial Summary
This trial is for people with a hard-to-control form of OCD. The goal is to find a more reliable system for treating OCD by studying how to best place electrodes in the brain to deliver electrical stimulation.
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 significant history of OCD symptoms causing distress and dysfunction. They cannot join if they have neurological disorders, high suicide risk, MRI contraindications, psychotic disorders like schizophrenia, or are pregnant.Check my eligibility
What is being tested?
The study aims to develop an adaptive Deep Brain Stimulation (aDBS) system for patients with hard-to-treat OCD. It involves surgically implanting electrodes in the brain connected to a chest device that sends electrical currents to alter brain function. The Phase Ib will involve implanting the RC+S system in two subjects.See study design
What are the potential side effects?
Potential side effects may include discomfort at the surgery site, infection risk from surgery, headache or pain related to stimulation adjustments, mood changes due to electrical current effects on the brain circuitry involved in emotion regulation.
Phase Ib Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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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I have completed 25 hours of a specific therapy for OCD without success.
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I have had OCD for over 5 years that hasn't improved with treatment and affects my daily life.
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I've tried and didn't respond to certain medications with added antipsychotics.
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I have tried clomipramine without success.
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I am between 21 and 70 years old.
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I have had OCD for over 5 years that hasn't improved with treatment and affects my daily life.
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I have tried at least three different SSRIs without success.
Phase Ib Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ [time frame: month 18]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame: month 18]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hypomania
Obsessive-Compulsive Personality
Secondary outcome measures
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity
Phase Ib Trial Design
2Treatment groups
Experimental Treatment
Group I: Summit RC+S DBS Implant for OCDExperimental Treatment1 Intervention
all subjects will receive surgical implantation of DBS system
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
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National Institute of Neurological Disorders and Stroke (NINDS)NIH
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed 25 hours of a specific therapy for OCD without success.I am between 21 and 70 years old.Your score on the Y-BOCS test must be at least 28.You need to have a minimum score of 28 on the Y-BOCS assessment.I have completed 25 hours of a specific therapy for OCD without success.I have had OCD for over 5 years that hasn't improved with treatment and affects my daily life.I've tried and didn't respond to certain medications with added antipsychotics.You score 8 or higher on a test that measures obsessive-compulsive behaviors.You have been assessed by a doctor and they believe you may be at a high risk of engaging in self-harm or impulsive behavior.I have tried clomipramine without success.I am between 21 and 70 years old.I have had OCD for over 5 years that hasn't improved with treatment and affects my daily life.You have a medical or neurological condition that, according to the doctor, makes you not suitable for the study.Sure, here are some simplified explanations of common exclusion criteria for participants in a study involving deep brain stimulation (DBS) for Obsessive-Compulsive Disorder (OCD):
1. Age: Participants must be within a certain age range to be eligible for the study.
2. Medical conditions: Participants with certain medical conditions, like bleeding disorders or active infections, may not be able to participate.
3. Mental health conditions: Participants with severe or unstable mental health conditions, other than OCD, may not be eligible.
4. Substance abuse: Participants with active substance abuse issues may be excluded from the study.
5. Pregnancy: Pregnant individuals are typically excluded due to potential risks to the fetus.
6. Previous DBS: Participants who have already had deep brain stimulation for OCD may not be eligible.
7. Inadequate response to previous treatments: Participants who have not adequately responded to other OCD treatments may be excluded.
Remember, these are simplified explanations and it's always best to consult the specific study protocol for accurate and detailed information.I have a neurological disorder or brain injury.My mental health medication has been stable for the last month.I have tried and not responded to additional treatment with specific antipsychotic drugs.You require diathermy (a medical procedure that uses heat) during the study.You have been diagnosed with a mental illness called schizophrenia.I have tried at least three different SSRIs without success.You have had problems with drinking too much alcohol or using drugs in the past 6 months, except for nicotine.You have a condition that makes it unsafe for you to have an MRI scan.You have been diagnosed with a mental illness at any point in your life.Criteria for including subjects in the OCD DBS study:
Research Study Groups:
This trial has the following groups:- Group 1: Summit RC+S DBS Implant for OCD
- Group 2: One Month Blinded Discontinuation Period
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any restrictions on who can participate in this research project?
"This clinical trial is admitting a maximum of three individuals aged between twenty-one and seventy, suffering from Obsessive Compulsive Disorder. Criteria for admission includes being male or female; having experienced OCD symptoms which cause significant distress and impairment to their life for at least five years; a minimum score of 28 on the Yale–Brown Obsessive Compulsive Scale (Y-BOCS); failed augmentation therapy with one of six antipsychotics; inadequate response to Cognitive Behavioral Therapy consisting 25 hours of Exposure Response Prevention provided by an expert therapist."
Answered by AI
Is this medical study open to individuals aged 45 and above?
"The requirements for this clinical trial stipulate that patients must be between 21 and 70 years old. There are 23 studies specifically tailored towards minors while 67 are geared to elderly individuals."
Answered by AI
Is there an open enrollment period for this clinical experiment?
"According to the information presented on clinicaltrials.gov, this medical study is not presently recruiting patients. Initially posted in October 2019 and last updated February 2022, there are 114 alternative trials enrolling individuals at present."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
University of Pittsburgh
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
California
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