Recruiting

tVNS & ERP

Sponsor:

University of Florida

Code:

NCT05580614

Conditions

OCD

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Sham

tVNS

Study Details

Brief summary:

In the proposed investigation, the investigator will develop pilot data for the use of tVNS (transcutaneous vagal nerve stimulation) to enhance efficacy of exposure and response prevention therapy (ERP) to improve treatment success in patients with OCD. This data will include tolerability information from therapists and patients with OCD, effect sizes on real world clinical outcomes for the combinatory treatment, and mechanistic data on brain changes associated with treatment.

Conditions

OCD

Study ID

NCT05580614

Start date

Jun 27, 2022

Status verified date

Oct, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active tVNS paired with 12 sessions of ERP

sham comparator: Sham tVNS paired with 12 sessions of ERP

Interventions

Sham

MRI (Magnetic Resonance Imaging) paired ERP/Sham YBOCs(Yale-Brown Obsessive Compulsive Scale) (4,8,12) OCI-R (every other session). YBOCs and OCI-R will also be administered at intake and 4 weeks post treatment.

tVNS

MRI (Magnetic Resonance Imaging) paired ERP/tVNS YBOC's (Yale-Brown Obsessive Compulsive Scale) (4, 8, 12) OCI-R (every other session). YBOCs and OCI-R will also be administered at intake and 4 weeks post treatment.

Primary outcome measure

  • Yale Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline up to 1 month post treatment ]

Central Contacts and Locations

Central contacts

Laura Jones, M.S.

352 265-0294laura.jones@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Robyn Nelson

352-294-5563r.nelson@ufl.edu

Principal Investigator:

John Williamson, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 9, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-09.