Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04455295

Enrollment

Registered

2020-07-02

Start date

2020-09-01

Completion date

2025-06-01

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electroencephalography, no Condition, Pupil Diameter

Brief 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.

Interventions

DEVICETransdermal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026