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Paired tVNS With ERP in OCD

NCT05580614 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-10-27

No results posted yet for this 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.

Conditions

  • OCD

Interventions

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.

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.

Sponsors & Collaborators

  • International OCD Foundation

    collaborator UNKNOWN

  • University of Florida

    lead OTHER

Principal Investigators

  • John Williamson, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2026-04-30
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580614 on ClinicalTrials.gov