Recruiting

Targeted Neuromodulation

Sponsor:

Mclean Hospital

Code:

NCT05048251

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

cTBS

iTBS

sham

Study Details

Brief summary:

Patients with obsessive-compulsive disorder (OCD) experience a wide array of different types of obsessions and compulsions. However, current treatments for OCD employ a "one size fits all" approach and are used for all patients regardless of symptom type. In this project, the investigators propose to investigate whether a novel method of transcranial magnetic stimulation specifically reduces contamination/washing symptoms - one of the most common types of OCD.

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT05048251

Start date

Jul 1, 2022

Status verified date

Mar, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. male or female age 18-55 years old
2. DSM-5 diagnosis of OCD as primary presenting disorder
3. CONTAM as the predominant symptom dimension (i.e., Dimension 4 (CONTAM symptoms) is the highest score on the Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS); participants with more than one Dimension as highest score will still be eligible as long as Dimension 4 is one of these)
4. score of ≥ 8 on Dimension 4 of the D-YBOCS
5. taking no psychiatric medications or on a stable dose of an SSRI, clomipramine, SNRI, or second generation antipsychotic for at least 4 weeks prior to enrollment. Use of PRN benzodiazepines will be permitted as long as the dose/usage has not changed significantly leading up to enrollment. No medication changes will be permitted during the study
6. have not initiated a new course of exposure and response prevention (ERP) therapy within 4 weeks of enrollment (ongoing ERP will be permitted if initiated more than 8 weeks before enrollment).

Exclusion Criteria:

1. positive urine drug screen (other than prescribed benzodiazepines)
2. use of psychiatric medications other than permitted above
3. substance use disorder in the last 3 months (with the exception of nicotine)
4. history of schizophrenia, bipolar disorder, autism, Tourette's syndrome (current and past history of depressive, anxiety, and eating disorders permitted as long as OCD is considered the primary disorder)
5. active suicidal ideation over the week prior to screening (as indicated by answering yes to questions 1 or 2 on the C-SSRS)
6. history of traumatic brain injury, seizure disorder, neurodegenerative disease, or other organic brain disease
7. pregnancy or lactating
8. contraindication to MRI scanning or TMS

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: cTBS

continuous TBS to right MFG

experimental: iTBS

intermittent TBS to right MFG

sham comparator: sham

sham stimulation to right MFG

Interventions

cTBS

continuous theta burst stimulation

iTBS

intermittent theta burst stimulation

sham

sham stimulation

Primary outcome measure

  • Functional connectivity between R MFG and brain regions within VAN (expressed as a Z-score) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

More Information

Sponsor

Mclean Hospital

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2024-03-15.