Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

Arkansas Tech University

Status: Active, not recruiting

Conditions: no Condition; Electroencephalography; Pupil Diameter

Treatments: Device: Transdermal Vagus Nerve Stimulation (tVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04455295

Roosevelt_102218

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 4 patient groups, including a placebo group

Active Stimulation 0.5

Experimental group

Description:

0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.

Treatment:

Device: Transdermal Vagus Nerve Stimulation (tVNS)

Lobe Control

Placebo Comparator group

Description:

0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles.

Treatment:

Device: Transdermal Vagus Nerve Stimulation (tVNS)

Sham Stimulation

Placebo Comparator group

Description:

0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.

Treatment:

Device: Transdermal Vagus Nerve Stimulation (tVNS)

Nonstimulation

Placebo Comparator group

Description:

Placement of electrode without any stimulation.

Treatment:

Device: Transdermal Vagus Nerve Stimulation (tVNS)