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Behavioural Intervention

tVNS + ERP for Obsessive-Compulsive Disorder

N/A
Recruiting
Led By John Williamson, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 month post treatment

Summary

This trial will research how combining tVNS and ERP can improve OCD treatment success. Therapists and patients will give feedback on how well it works.

Who is the study for?
This trial is for adults aged 18-50 with moderate to severe Obsessive-Compulsive Disorder (OCD), as indicated by a YBOCS score of 15 or higher. Participants must be able to consent and have been on stable medication doses for at least six weeks. Those with drug abuse issues, major neurological conditions, active eating disorders, or recent ERP therapy are excluded.
What is being tested?
The study tests if tVNS (non-invasive nerve stimulation) can boost the effectiveness of exposure and response prevention therapy in OCD treatment. It will measure tolerability, impact on OCD symptoms, and brain changes due to the combined treatment approach.
What are the potential side effects?
While specific side effects are not listed here, tVNS generally may cause discomfort at the stimulation site, headache, voice changes or hoarseness. Side effects from ERP could include temporary increases in anxiety and distress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 month post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 month post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Yale Brown Obsessive-Compulsive Scale (Y-BOCS)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active tVNS paired with 12 sessions of ERPActive Control1 Intervention
Group II: Sham tVNS paired with 12 sessions of ERPPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,399 Previous Clinical Trials
767,023 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
303 Patients Enrolled for Obsessive-Compulsive Disorder
International OCD FoundationUNKNOWN
2 Previous Clinical Trials
99 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
99 Patients Enrolled for Obsessive-Compulsive Disorder
John Williamson, PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Exposure and Response Prevention Therapy (ERP) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05580614 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Active tVNS paired with 12 sessions of ERP, Sham tVNS paired with 12 sessions of ERP
Obsessive-Compulsive Disorder Clinical Trial 2023: Exposure and Response Prevention Therapy (ERP) Highlights & Side Effects. Trial Name: NCT05580614 — N/A
Exposure and Response Prevention Therapy (ERP) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05580614 — N/A
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05580614 — N/A
~17 spots leftby Nov 2025
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