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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life as measured by the Short-Form 36

Secondary study objectives

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

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: 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

0 / 4Eligibility criteria met