Paired tVNS With ERP in OCD

Not Applicable

Recruiting

• Conditions: OCD
• Interventions: Device: Sham; Device: tVNS

• Registration Number: NCT05580614
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-27
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tVNS paired with 12 sessions of ERP	Sham	-
Active tVNS paired with 12 sessions of ERP	tVNS	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States