Paired tVNS With ERP in OCD

Pairing tVNS and Exposure and Response Prevention to Improve Symptoms of OCD

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.

Study Overview

• Status: Recruiting
• Conditions: OCD
• Intervention / Treatment: Device: tVNS; Device: Sham

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer DeHart; Phone Number: 352-316-7154; Email: jdehart@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: John Williamson, PhD
      • Contact: Jennifer DeHart; Phone Number: 352-316-7154; Email: jdehart@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tVNS paired with 12 sessions of ERP	Device: 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.
Sham Comparator: Sham tVNS paired with 12 sessions of ERP	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: International OCD Foundation
• Investigators: Principal Investigator: John Williamson, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB202101733; OCR41263 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes