NCT05580614

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jun 2022Aug 2026

Study Start

First participant enrolled

June 27, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

3.8 years

First QC Date

October 12, 2022

Last Update Submit

October 24, 2025

Conditions

OCD

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive-Compulsive Scale (Y-BOCS)

    A test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. The 10 Y-BOCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions, and the sum of the last five an index for compulsions. Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms. The scale can also provide a subscale score for obsessions and compulsions (range 0-20) separately.

    Baseline up to 1 month post treatment

Study Arms (2)

Active tVNS paired with 12 sessions of ERP

ACTIVE COMPARATOR
Device: tVNS

Sham tVNS paired with 12 sessions of ERP

SHAM COMPARATOR
Device: Sham

Interventions

ShamDEVICE

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.

Sham tVNS paired with 12 sessions of ERP
tVNSDEVICE

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.

Active tVNS paired with 12 sessions of ERP

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Study Officials

  • John Williamson, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Jones, M.S.

CONTACT

352 265-0294laura.jones@ufl.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 14, 2022

Study Start

June 27, 2022

Primary Completion

April 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

October 27, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)