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Deep Brain Stimulation
Deep Brain Stimulation for Obsessive-Compulsive Disorder
N/A
Waitlist Available
Led By Darin D Dougherty, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 21 and 65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new treatment for people with OCD that has not been helped by other treatments. The treatment is called deep brain stimulation, and it involves placing a device in the brain to send electrical signals.
Who is the study for?
Adults aged 21-65 with severe OCD, not improved after multiple treatments including drugs and behavioral therapy, can join this trial. They must be in good health, understand the study, consent to it, have a supportive family member or friend, and live near the study site. Excluded are those with psychotic disorders, low IQ/cognitive impairments affecting consent ability, bipolar disorder history, MRI contraindications like metal implants or claustrophobia.Check my eligibility
What is being tested?
The Medtronic PC+S deep brain stimulation device is being tested as a treatment for patients with intractable OCD. This involves surgical implantation of electrodes into specific brain areas to modulate activity through electrical impulses.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, headache following surgery or stimulation adjustments; risk of infection; possible changes in mood or behavior; and rarely bleeding inside the brain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Secondary outcome measures
Clinical Global Impressions (CGI) Severity and Change scale
Montgomery-Asberg Depression Rating Scale (MADRS)
Patient Global Impressions (PGI) scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Medtronic Percept Deep Brain StimulationExperimental Treatment1 Intervention
Single open label arm.
Patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) will receive stimulation in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic Percept deep brain stimulation (DBS) system.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,353 Total Patients Enrolled
26 Trials studying Obsessive-Compulsive Disorder
1,630 Patients Enrolled for Obsessive-Compulsive Disorder
Darin D Dougherty, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
110 Total Patients Enrolled
4 Trials studying Obsessive-Compulsive Disorder
50 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 65 years old.I am not pregnant and if of childbearing age, I use effective contraception.I am in good health overall.I have not changed my medications in the last 6 weeks.I cannot have an MRI due to a pacemaker, metal in my body, pregnancy, or severe claustrophobia.I do not have any brain-affecting illnesses except for tic disorders or Tourette syndrome.I've had severe symptoms for 5+ years despite trying multiple treatments.I have not changed my medications in the last 6 weeks.I've had severe symptoms for 5+ years despite trying multiple treatments.I am between 21 and 65 years old.I can understand and sign the consent form.I have severe OCD with a YBOCS score of 28 or more.
Research Study Groups:
This trial has the following groups:- Group 1: Medtronic Percept Deep Brain Stimulation
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.
What is the current sample size of individuals participating in this clinical investigation?
"Affirmative. The information hosted on clinicaltrials.gov suggests that this medical study is still recruiting participants, having been initially posted on March 1st 2019 and last updated November 3rd 2022. There are 5 spots to be filled at 2 different sites of the trial location."
Answered by AI
Would I be eligible for participation in this research project?
"To be eligible for this clinical trial, individuals must have compulsive tendencies and fall within the 21-65 age range. In total, they need to recruit 5 participants."
Answered by AI
Is this experiment open to participants who are of age 20 or above?
"This clinical trial has an age range requirement where patients need to be at least 21 years old and no older than 65 in order to qualify."
Answered by AI
Are there still opportunities for participants to take part in this clinical experiment?
"Affirmative. Information posted on clinicaltrials.gov confirms that this research endeavour is currently enrolling participants, having been first opened to the public on March 1st 2019 and last updated on November 3rd 2022. The project seeks out 5 individuals from 2 different sites for participation in the trial."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
Minnesota
How old are they?
18 - 65
What site did they apply to?
University of Minnesota
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- University of Minnesota: < 48 hours
- Massachusetts General Hospital: < 48 hours
Average response time
- < 2 Days
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