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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of subjects that display biomarkers of DBS-induced 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
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
1,339 Previous Clinical Trials
649,388 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,008 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
456 Previous Clinical Trials
563,079 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
467 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,719 Previous Clinical Trials
16,342,339 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this trial open to participants?
"This research project is only available to people between 21 and 70 who have been diagnosed with obsessive-compulsive disorder. The clinical trial will accept up to two participants for the study."
Answered by AI
Are there any openings left in this clinical research project?
"The information listed on clinicaltrials.gov attests that this medical trial is not presently recruiting patients. Initially advertised in July 2018, it was last updated a few months ago in February 2022. Despite the cessation of patient recruitment for this particular study, there are 114 other trials actively enrolling participants at present."
Answered by AI
Is this study inclusive of geriatric participants?
"As per the stipulations of this trial, prospective enrollees should be within the age range of 21 to 70. 23 trials are available for younger patients while 67 studies are open to those over 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Texas
North Carolina
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?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
I’d like to know how many treatments?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have harm ocd which is very lonely I can’t really talk to anyone about except a therapist.
PatientReceived no prior treatments
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