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NCT04455295 Clinical Trial

Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

Electroencephalography Clinical Trial

Official title:
Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04455295
Other study ID # Roosevelt_102218
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date June 1, 2025

Study information
Verified date February 2024
Source Arkansas Tech University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 55
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthy, 18 years of age or older. Exclusion Criteria: - self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transdermal Vagus Nerve Stimulation (tVNS)
Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies.

Locations
Country Name City State
United States Arkansas Tech University Russellville Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Tech University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pupil Diameter Pupil diameter is measured via camera. Within single one hour session
Primary EEG Alpha power. Alpha power will be determined from EEG. Within single one hour session
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