Active tVNS paired with 12 sessions of ERP for Obsessive-Compulsive Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obsessive-Compulsive Disorder
tVNS - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Obsessive-Compulsive Disorder

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline up to 1 month post treatment

Month 1
Yale Brown Obsessive-Compulsive Scale (Y-BOCS)

Trial Safety

Safety Progress

1 of 3

Other trials for Obsessive-Compulsive Disorder

Trial Design

2 Treatment Groups

Active tVNS paired with 12 sessions of ERP
1 of 2
Sham tVNS paired with 12 sessions of ERP
1 of 2
Active Control
Non-Treatment Group

56 Total Participants · 2 Treatment Groups

Primary Treatment: Active tVNS paired with 12 sessions of ERP · Has Placebo Group · N/A

Sham tVNS paired with 12 sessions of ERP
Device
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Device
Active tVNS paired with 12 sessions of ERP
Device
ActiveComparator Group · 1 Intervention: tVNS · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 1 month post treatment

Who is running the clinical trial?

University of FloridaLead Sponsor
1,236 Previous Clinical Trials
696,979 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
303 Patients Enrolled for Obsessive-Compulsive Disorder
International OCD FoundationUNKNOWN
2 Previous Clinical Trials
118 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
118 Patients Enrolled for Obsessive-Compulsive Disorder
John Williamson, PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for the study if you are between the ages of 18 and 50.
You have OCD, based on a structured clinical interview and who have a YBOCS score of 15 or higher, indicating at least moderate OCD severity.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.