N/A N=10 Randomized Basic Science

Home Operations Utilizing Stimulation

Cognitive Performance

Bottom Line

View on ClinicalTrials.gov: NCT04484285 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: System Usability Scale — 46.25; 10 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcutaneous Vagal Nerve Stimulation (tVNS) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY System Usability Scale	46.25; 10	—

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.

Eligibility Criteria

Inclusion Criteria

Participants for one cohort will be adults between the ages of 18-55, consistent with the typical college population
Participants for the other cohort will be adults between the ages of 56 - 85. Participants must read and write English.

Exclusion Criteria

Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) will be excluded. Participants with any history of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices will be excluded.
Sleep medications and/or psychostimulants are exclusionary. Subjects in the older cohort will NOT be excluded for taking blood pressure and cholesterol medication. Participants who are pregnant will be excluded. If participants have a history of adverse reaction to electrical nerve stimulation, they will be excluded.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04484285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.