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Adaptive DBS 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
OCD DBS Subject Inclusion criteria: Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole
OCD DBS Subject Inclusion criteria: Male or female between ages 21 and 70
Must not have
Implanted ET Subject Exclusion criteria: Any other neurological disorder other than ET (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
Non-Implanted Control Subject Exclusion criteria: Pregnant (confirmed by self-report for females of child bearing age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights
No Placebo-Only Group
Summary
This trial is for people with OCD who have not responded to other treatments. The goal is to use signals from the brain to automatically adjust the Deep Brain Stimulation (DBS) stimulation factors to improve symptom management and reduce stimulation-induced behavioral side effects.
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 impairment, not be at high risk of suicide or impulsivity, and cannot have other major neurological conditions or be pregnant.
What is being tested?
The study tests an adaptive Deep Brain Stimulation (aDBS) system in patients with hard-to-treat OCD. It involves surgically placing electrodes in the brain to regulate abnormal activity. The goal is to improve symptom management and reduce side effects by adjusting stimulation based on brain signals.
What are the potential side effects?
Potential side effects may include risks associated with brain surgery such as infection, bleeding, headache or discomfort at the implant site. DBS can also cause mood changes, unusual sensations or involuntary movements due to electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My OCD wasn't helped by adding antipsychotics to my treatment.
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I am between 21 and 70 years old.
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I have had OCD for over 5 years, and treatments haven't worked well for me.
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I have tried at least three different SSRIs for my OCD without success.
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I have tried clomipramine for OCD without success.
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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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I have Essential Tremor without head tremor and have a DBS implant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I only have Essential Tremor and no other neurological conditions or brain injuries.
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I am not pregnant.
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I have never been diagnosed with a mental illness in my life.
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I do not have neurological disorders or brain injuries.
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I have never been diagnosed with schizophrenia or similar conditions.
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
Percent of subjects that display biomarkers of DBS-induced 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: One Month Blinded Discontinuation PeriodExperimental Treatment1 Intervention
all subjects will enter a one-month blinded discontinuation period to confirm clinical benefit at the end of Month 8.
Group II: Activa PC+S DBS implant for OCDExperimental Treatment1 Intervention
all subjects will receive surgical implantation of DBS system
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,380 Previous Clinical Trials
652,181 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,008 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
466 Previous Clinical Trials
699,068 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
467 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,789 Previous Clinical Trials
16,359,621 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
152 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My OCD wasn't helped by adding antipsychotics to my treatment.I only have Essential Tremor and no other neurological conditions or brain injuries.I am between 21 and 70 years old.I have had OCD for over 5 years, and treatments haven't worked well for me.I have tried and not responded to specific antipsychotic drugs.People who can participate in the study for OCD deep brain stimulation (DBS) must meet the following requirements:I have had OCD for over 5 years that hasn't improved with treatment and significantly affects my daily life.Your score on the Y-BOCS test must be at least 28.I have tried clomipramine without success.I am not pregnant.I have completed 25 hours of a specific therapy for OCD without success.I'm sorry, but the provided criterion seems to be incomplete. Could you please provide more details or clarify the inclusion criteria for implanted ET subjects?I have Essential Tremor without head tremor and have a DBS implant.I have never been diagnosed with a mental illness in my life.I do not have neurological disorders or brain injuries.I have tried at least three different SSRIs for my OCD without success.I have tried clomipramine for OCD without success.I have completed 25 hours of a specific therapy for OCD without success.My medication for mental health has not changed in the last month.I am between 21 and 70 years old.I have Essential Tremor without head tremor and have a DBS implant.I have completed 25 hours of a specific therapy for OCD without success.I am between 21 and 70 years old.I have never been diagnosed with schizophrenia or similar conditions.I am between 21 and 70 years old.I am between 21 and 70 years old.You have a minimum score of 28 on the Y-BOCS test, which measures the severity of obsessive-compulsive disorder.I have had OCD for over 5 years that hasn't improved with treatment and significantly affects my daily life.
Research Study Groups:
This trial has the following groups:- Group 1: Activa PC+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.
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