NCT07424365

Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations

Investigation of Vagus Nerve Stimulation to Augment Executive Functioning

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study plans to learn more about how stimulating the vagus nerve through gentle electrical stimulation applied to the ear can affect decision-making, problem-solving, and other thinking abilities. This process, called transcutaneous auricular vagus nerve stimulation (taVNS), could help improve brain function in both healthy individuals and people with Parkinson's disease (PD).

Detailed description

This is a single-site pilot study to assess the safety, feasibility, and potential therapeutic effect of paired-taVNS cognitive training in healthy individuals and people with PD. In the longitudinal study, healthy and PD participants will be prospectively assigned to receive either the sham or active intervention based on order of enrollment in the study. In the acute study, healthy participants will receive both the sham and active intervention, where the order will be prospectively randomized based on order of enrollment in the study.

Conditions

• Mild Cognitive Impairment (MCI)
• Parkinsons Disease (PD)
• Healthy Adult

Interventions

Type	Name	Description
DEVICE	transcutaneous auricular vagus nerve stimulation	Electrical stimulation targeting the auricular branch of the vagus nerve
DEVICE	sham stimulation	Sham stimulation of the outer ear that does not target the vagus nerve

Timeline

• Start date: 2025-05-19
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study