NCT05580614

Paired tVNS With ERP in OCD

Pairing tVNS and Exposure and Response Prevention to Improve Symptoms of OCD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-06-27
• Primary completion: 2026-04-30
• Completion: 2026-08-31
• First posted: 2022-10-14
• Last updated: 2025-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study