NCT06589362

Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).

Detailed description

Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of executive functions. The order of the sessions (tVNS vs Sham) will be counterbalanced across participants.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Transcutaneous auricular vagus active nerve stimulation	In the active stimulation, two electrodes are placed in the cymba conchae of one of the ears, an area thought to be exclusively innervated by the auricular branch of the vagus nerve.
DEVICE	Transcutaneous auricular vagus sham nerve stimulation	In the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation.

Timeline

• Start date: 2024-09-07
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2024-09-19
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study