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Device

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 below
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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:
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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 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

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
1,385 Previous Clinical Trials
652,686 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,008 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
466 Previous Clinical Trials
699,078 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
467 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,792 Previous Clinical Trials
16,359,984 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
152 Patients Enrolled for Obsessive-Compulsive Disorder
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,086 Total Patients Enrolled
5 Trials studying Obsessive-Compulsive Disorder
75 Patients Enrolled for Obsessive-Compulsive Disorder
Carnegie Mellon UniversityOTHER
77 Previous Clinical Trials
539,893 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
20 Patients Enrolled for Obsessive-Compulsive Disorder
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,160 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
770 Patients Enrolled for Obsessive-Compulsive Disorder
Wayne Goodman, MDPrincipal InvestigatorBaylor College of Medicine
7 Previous Clinical Trials
159 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
149 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Activa PC+S DBS implant for OCD (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03457675 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Activa PC+S DBS implant for OCD, One Month Blinded Discontinuation Period
Obsessive-Compulsive Disorder Clinical Trial 2023: Activa PC+S DBS implant for OCD Highlights & Side Effects. Trial Name: NCT03457675 — N/A
Activa PC+S DBS implant for OCD (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03457675 — N/A
~0 spots leftby Jun 2025
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