Using transcutaneous vagal nerve stimulation to improve therapy for OCD
Pairing tVNS and Exposure and Response Prevention to Improve Symptoms of OCD
NA · University of Florida · NCT05580614
This study is testing if adding a new treatment called transcutaneous vagal nerve stimulation to therapy can help adults with obsessive-compulsive disorder feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05580614 on ClinicalTrials.gov |
What this trial studies
This investigation aims to gather pilot data on the effectiveness of transcutaneous vagal nerve stimulation (tVNS) combined with exposure and response prevention therapy (ERP) for treating obsessive-compulsive disorder (OCD). The study will assess the tolerability of this combined treatment from both therapists and patients, measure its impact on clinical outcomes, and explore brain changes associated with the treatment. Participants will be adults aged 18 to 55 who meet specific criteria for OCD severity. The study will utilize both sham and active tVNS interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 55 with moderate to severe OCD symptoms.
Not a fit: Patients with major neurological conditions or severe medical diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance treatment outcomes for patients with OCD.
How similar studies have performed: While the combination of tVNS and ERP is a novel approach, similar studies have shown promise in enhancing treatment efficacy for various conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults between the ages of 18 and 55 * Meet DSM-5 criteria for OCD, based on a structured clinical interview and who have a YBOCS score of 15 or higher, indicating at least moderate OCD severity * Participants must be willing and able to provide informed consent. Exclusion Criteria: * Participants with major neurological conditions, autism spectrum disorder, psychosis, major uncorrected sensory deficit, and severe medical disease that may be associated with neurological effects. * People with an active eating disorder that requires treatment, but we will not exclude people who are in remission. * Current illicit or prescription drug abuse * Participants who are receiving pharmacotherapy for their OCD or for other psychiatric disorders will not be excluded * No medication changes will be allowed during the study, and participants must be on stable doses of medications for at least 6 weeks prior to entering the study. Prior ERP treatment (at least 12 months removed) is acceptable
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: John Williamson, PhD — University of Florida
- Study coordinator: Laura Jones, M.S.
- Email: laura.jones@ufl.edu
- Phone: 352 265-0294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: OCD