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Paired tVNS With ERP in OCD

This study is exploring if transcutaneous vagal nerve stimulation (tVNS) can improve the effectiveness of exposure and response prevention therapy (ERP) for people with Obsessive-Compulsive Disorder (OCD). Researchers want to see if combining tVNS with ERP leads to better treatment success. They will also gather information on how well patients and therapists tolerate this combined treatment and look for changes in the brain. You may be able to join if you are an adult between 18 and 55 years old, have been diagnosed with OCD, and have a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 15 or higher. The main way success will be measured is by changes in your Y-BOCS score from the start of the study up to one month after treatment. The current status of this study is unclear.

Study design
This interventional study plans to enroll 56 participants. It compares two groups: one receiving tVNS paired with ERP, and another receiving a sham device paired with ERP.
What's involved
You would undergo MRI scans and receive either tVNS or a sham device paired with ERP. You would also complete YBOCS and OCI-R assessments at intake, at 4, 8, and 12 weeks during treatment, and 4 weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
Your Y-BOCS score will be measured up to one month after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05580614

Paired tVNS With ERP in OCD

Recruiting
NAAges 18–55InterventionalTreatment
University of Florida
~56 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:ShamtVNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Yale Brown Obsessive-Compulsive Scale (Y-BOCS)
Measured over Baseline up to 1 month post treatment

Conditions

OCD

Explore related trials

Obsessive Compulsive Disorder

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • John Williamson, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Laura Jones, M.S.
[email protected]
352 265-0294
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Yale Brown Obsessive-Compulsive Scale (Y-BOCS)Baseline up to 1 month post treatment

    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.