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
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
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: DeviceActive tVNS paired with 12 sessions of ERP
Device
ActiveComparator Group · 1 Intervention: tVNS · Intervention Types: DeviceTrial 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 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.
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