Targeted brain stimulation for contamination-based OCD

Individually Targeted Neuromodulation for Contamination-based Obsessive-compulsive Disorder

This study is testing a new brain stimulation treatment to see if it can help people with OCD who struggle with contamination and washing symptoms feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Mclean Hospital (other)
• Locations: 1 site (Belmont, Massachusetts)
• Trial ID: NCT05048251 on ClinicalTrials.gov

What this trial studies

This study investigates a novel method of transcranial magnetic stimulation (TMS) aimed at reducing contamination and washing symptoms in patients with obsessive-compulsive disorder (OCD). It focuses on the specific brain networks associated with these symptoms, utilizing advanced imaging techniques to identify connectivity patterns. The approach is designed to personalize treatment by targeting the right medial frontal gyrus and its connections to the ventral attention network, which are believed to play a role in the severity of contamination symptoms. The study will involve a two-phase program to assess the effectiveness of this targeted intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 with a primary diagnosis of OCD and predominant contamination symptoms.

Not a fit: Patients with OCD who do not primarily experience contamination symptoms or those on certain psychiatric medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatments for patients suffering from contamination-based OCD.

How similar studies have performed: While there have been studies on TMS for OCD, this specific targeted approach is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Belmont, Massachusetts

• McLean Hospital — Belmont, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Brian P Brennan, MD — Mclean Hospital
• Study coordinator: Rosalind Sokoll

Conditions: Obsessive-Compulsive Disorder