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Deep Brain Stimulation

ON stimulation followed by OFF stimulation for Obsessive-Compulsive Disorder

Q: What kind of participants are ideal for this trial?

This trial is looking for a number of volunteers with obsessive-compulsive disorder that are between 18 and 70 years old. Up to 10 participants will be accepted into the study.

Q: Is enrollment for this research project still open?

According to the information on clinicaltrials.gov, this particular study is not currently recruiting participants. This research project was first posted in September 2019 and last edited in March 2021; however there are many other trials that require volunteers at present.

Q: Is the age limit for participants in this study restricted to those below 25 years of age?

To be considered for this trial, the applicants must fall between 18 and 70 years of age. There are 21 trials specifically designed to include participants under 18 and 73 studies tailored towards those over 65 years old.

Q: What risks are posed by the alternating ON and OFF stimulation protocol for participants?

Our team at Power graded the safety of ON stimulation followed by OFF stimulation a 2 since it is only in its second phase. This means that although there is some evidence supporting its safety, there is none pointing to efficacy.

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

Study 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 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

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

~380

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,612 Total Patients Enrolled

9 Trials studying Obsessive-Compulsive Disorder

800 Patients Enrolled for Obsessive-Compulsive Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of participants are ideal for this trial?

"This trial is looking for a number of volunteers with obsessive-compulsive disorder that are between 18 and 70 years old. Up to 10 participants will be accepted into the study."

Answered by AI

Is enrollment for this research project still open?

"According to the information on clinicaltrials.gov, this particular study is not currently recruiting participants. This research project was first posted in September 2019 and last edited in March 2021; however there are many other trials that require volunteers at present."

Answered by AI

Is the age limit for participants in this study restricted to those below 25 years of age?

"To be considered for this trial, the applicants must fall between 18 and 70 years of age. There are 21 trials specifically designed to include participants under 18 and 73 studies tailored towards those over 65 years old."

Answered by AI

What risks are posed by the alternating ON and OFF stimulation protocol for participants?

"Our team at Power graded the safety of ON stimulation followed by OFF stimulation a 2 since it is only in its second phase. This means that although there is some evidence supporting its safety, there is none pointing to efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Deep Brain Stimulation (DBS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)

Dr. Nir Lipsman 2019. "Deep Brain Stimulation (DBS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04217408.

All > Obsessive Compulsive Disorder > Ocd