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Deep Brain Stimulation

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female or Male patients between age 18-70
SF-36<40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial uses electricity to treat neurological disorders that medicines can't fix.

Who is the study for?
This trial is for adults aged 18-70 with a confirmed diagnosis of Obsessive Compulsive Disorder (OCD) who have struggled with the condition for at least five years. Participants should have tried and not responded to two or more first-line OCD medications and augmentation by at least one medication, as well as cognitive behavioral therapy. They must be able to consent to the study and follow all procedures.Check my eligibility
What is being tested?
The trial is testing Deep Brain Stimulation (DBS) as a treatment option for those with treatment-resistant OCD. DBS involves using electrical impulses to stimulate specific parts of the brain that are involved in OCD symptoms.See study design
What are the potential side effects?
Potential side effects of DBS can include headache, seizure, confusion, difficulty concentrating, mood changes like depression or mania, and infection risk from the surgery required to implant stimulation devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My quality of life score is below 40.
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I have tried at least two first-line treatments for OCD without success.
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I have been diagnosed with OCD for over 5 years and have a severe case.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of Life as measured by the Short-Form 36
Secondary outcome measures
Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale
Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization

Trial Design

2Treatment groups
Experimental Treatment
Group I: ON stimulation followed by OFF stimulationExperimental Treatment1 Intervention
All patients complete the same 52 week open-label phase with active stimulation. After this, they enter a blinded randomized crossover phase of 2 weeks of ON (active) stimulation, followed by 2 weeks of OFF (sham) stimulation
Group II: OFF stimulation followed by ON stimulationExperimental Treatment1 Intervention
All patients complete the same 52 week open-label phase with active stimulation. After this, they enter a blinded randomized crossover phase of 2 weeks of OFF (sham) stimulation, followed by 2 weeks of ON (active) stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
661 Previous Clinical Trials
1,554,041 Total Patients Enrolled
9 Trials studying Obsessive-Compulsive Disorder
800 Patients Enrolled for Obsessive-Compulsive Disorder
~1 spots leftby Dec 2024
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