Individually Targeted Neuromodulation for Contamination-based OCD

NCT05048251 | Recruiting DMC FDA Device

• 1 other identifier: 2021P000141
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Functional connectivity between R MFG and brain regions within VAN (expressed as a Z-score)

  Change in functional connectivity between: 1) R MFG and right temporoparietal junction (R TPJ); 2) R MFG and left temporoparietal junction (L TPJ); 3) R MFG and right inferior frontal gyrus (R IFG); 4) R MFG and left inferior frontal gyrus (L IFG); 5) R MFG and right anterior insula (R AI); 6) R MFG and left anterior insula (L AI); 7) R MFG and right posteromedial putamen; and 8) R MFG and left posteromedial putamen

  6 weeks

Secondary Outcomes (3)

• Functional activation of R MFG and brain regions within VAN during an RSVP task (expressed as a beta value)

  6 weeks

• Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS)

  6 weeks

• Yale-Brown Obsessive Compulsive Scale (YBOCS)

  6 weeks

Study Arms (3)

cTBS

EXPERIMENTAL

continuous TBS to right MFG

Device: cTBS

iTBS

EXPERIMENTAL

intermittent TBS to right MFG

Device: iTBS

sham

SHAM COMPARATOR

sham stimulation to right MFG

Device: sham

Interventions

cTBS DEVICE

continuous theta burst stimulation

cTBS

iTBS DEVICE

intermittent theta burst stimulation

iTBS

sham DEVICE

sham stimulation

sham

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male or female age 18-55 years old
• DSM-5 diagnosis of OCD as primary presenting disorder
• 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)
• score of ≥ 8 on Dimension 4 of the D-YBOCS
• 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
• 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).

You may not qualify if:

• positive urine drug screen (other than prescribed benzodiazepines)
• use of psychiatric medications other than permitted above
• substance use disorder in the last 3 months (with the exception of nicotine)
• 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)
• active suicidal ideation over the week prior to screening (as indicated by answering yes to questions 1 or 2 on the C-SSRS)
• history of traumatic brain injury, seizure disorder, neurodegenerative disease, or other organic brain disease
• pregnancy or lactating
• contraindication to MRI scanning or TMS

Sponsors & Collaborators

• Mclean Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Brian P Brennan, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalind Sokoll

CONTACT

617-855-2911; rsokoll@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Obsessive-Compulsive Disorder Institute

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 17, 2021
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)