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Neuromodulation

Targeted Neuromodulation for Obsessive-Compulsive Disorder

N/A
Recruiting
Led By Brian P Brennan, MD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-5 diagnosis of OCD as primary presenting disorder
Male or female age 18-55 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will test whether a new method of transcranial magnetic stimulation can specifically help people with OCD who experience contamination/washing symptoms.

Who is the study for?
This trial is for adults aged 18-55 with Obsessive-Compulsive Disorder (OCD), specifically those who struggle mainly with contamination/washing symptoms. Participants should score ≥8 on a specific OCD scale and not have started new therapy or changed medications recently. It's not open to individuals using certain psychiatric drugs, those with a recent substance use disorder, or anyone pregnant.Check my eligibility
What is being tested?
The study tests individually targeted neuromodulation techniques: iTBS and cTBS against a sham procedure to see if they can reduce contamination-based OCD symptoms more effectively than current general treatments.See study design
What are the potential side effects?
While the description doesn't specify side effects, transcranial magnetic stimulation can sometimes cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My main diagnosis is OCD according to DSM-5.
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional connectivity between R MFG and brain regions within VAN (expressed as a Z-score)
Secondary outcome measures
Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS)
Functional activation of R MFG and brain regions within VAN during an RSVP task (expressed as a beta value)
Yale-Brown Obsessive Compulsive Scale (YBOCS)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: iTBSExperimental Treatment1 Intervention
intermittent TBS to right MFG
Group II: cTBSExperimental Treatment1 Intervention
continuous TBS to right MFG
Group III: shamPlacebo Group1 Intervention
sham stimulation to right MFG
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iTBS
2019
Completed Phase 3
~640
cTBS
2013
N/A
~50

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
212 Previous Clinical Trials
21,793 Total Patients Enrolled
9 Trials studying Obsessive-Compulsive Disorder
693 Patients Enrolled for Obsessive-Compulsive Disorder
Massachusetts General HospitalOTHER
2,903 Previous Clinical Trials
13,185,498 Total Patients Enrolled
26 Trials studying Obsessive-Compulsive Disorder
1,582 Patients Enrolled for Obsessive-Compulsive Disorder
Brian P Brennan, MDPrincipal InvestigatorMclean Hospital
3 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

cTBS (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05048251 — N/A
Obsessive-Compulsive Disorder Research Study Groups: cTBS, iTBS, sham
Obsessive-Compulsive Disorder Clinical Trial 2023: cTBS Highlights & Side Effects. Trial Name: NCT05048251 — N/A
cTBS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05048251 — N/A

Frequently Asked Questions

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

What is the most populous cohort of individuals participating in this research?

"Affirmative. According to records on clinicaltrials.gov, this medical experiment – which was initialy posted on July 1st 2022 – is actively seeking out potential participants. There are 50 spots to fill at one trial site."

Answered by AI

Are any individuals aged 20 or over permitted to join this experiment?

"In order to be considered for this medical study, the applicant must fall between 18 and 55 years old as stipulated in the eligibility requirements."

Answered by AI

Are there any open slots remaining for this trial?

"Affirmative. Clinicaltrials.gov data shows that this clinical trial is still searching for participants as of November 14th, 2022; the study was initially published on July 1st, 2022 and requires 50 enrollees at a single site."

Answered by AI

Can I join the research project?

"This trial seeks 50 individuals aged 18 to 55, who struggle with obsessive-compulsive disorder. Crucially, they must have CONTAM as their foremost symptom dimension (highest score on the Dimensional Yale-Brown Obsessive Compulsive Scale), not initiate a new course of exposure and response prevention therapy within 8 weeks of enrollment (continuing ERP will be allowed if begun more than 8 weeks before enrolment) and achieve at least an 8/20 on Dimension 4 of the DYBOCS."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Texas
What portion of applicants met pre-screening criteria?
Met criteria
How old are they?
18 - 65
What site did they apply to?
McLean Hospital
~9 spots leftby Jun 2024