NCT04484285

Home Operations Utilizing Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This project will utilize a home-operated stimulator in 1) a healthy young adult population and 2) a healthy older adult population to provide a proof of concept of home-use of transcutaneous vagal nerve stimulation (tVNS). tVNS is believed to modulate cognitive performance.

Detailed description

The vagal nerve is a major component of the autonomic nervous system and mediates the physiological responses of major organs during moments of stress and learning, including brain areas that modulate cognitive performance. Vagal nerve stimulation (VNS) has been indicated to improve stress response and to enhance neuroplasticity by directly impacting brain structures critical for cognition. Historically, VNS methods required neurosurgery and were reserved for medically intractable epilepsy or other severe conditions. Today, vagal nerve stimulation can be performed with a minimal-risk non-invasive approach without surgery through a technique called transcutaneous Vagal Nerve Stimulation (tVNS). This project will utilize a home-operated stimulator in healthy young adult and healthy older populations to provide a proof of concept of practical home-use stimulation.

Conditions

• Cognitive Performance

Interventions

Type	Name	Description
DEVICE	Transcutaneous Vagal Nerve Stimulation (tVNS)	vagal nerve stimulation

Timeline

• Start date: 2020-08-20
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2020-07-23
• Last updated: 2025-04-20
• Results posted: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study