Individually Targeted Neuromodulation for Contamination-based OCD
Recruiting · NCT05048251 · Interventional (participants receive a specific treatment) · Lead sponsor: Mclean Hospital
View the official record on ClinicalTrials.gov →Interventions studied
cTBSiTBSsham
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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).
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- McLean Hospital - Belmont, Massachusetts, United States