Paired tVNS With ERP in OCD

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05580614
Status
Recruiting
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Conditions

  • OCD

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Sham — DEVICE
    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.
  • tVNS — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 27, 2022
Status verified
Oct 2025
Primary completion
Apr 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active tVNS paired with 12 sessions of ERP
  • Sham Comparator: Sham tVNS paired with 12 sessions of ERP

Primary Outcome Measure

Yale Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline up to 1 month post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Robyn Nelson
[email protected]
352-294-5563
John Williamson, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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