Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

NCT04455295 | Active Not Recruiting

• 1 other identifier: Roosevelt_102218
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

no Condition; Electroencephalography; Pupil Diameter

Outcome Measures

Primary Outcomes (2)

• Pupil Diameter

  Pupil diameter is measured via camera.

  Within single one hour session

• EEG Alpha power.

  Alpha power will be determined from EEG.

  Within single one hour session

Study Arms (4)

Active Stimulation 0.5

EXPERIMENTAL

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

Device: Transdermal Vagus Nerve Stimulation (tVNS)

Lobe Control

PLACEBO COMPARATOR

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

Device: Transdermal Vagus Nerve Stimulation (tVNS)

Sham Stimulation

PLACEBO COMPARATOR

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

Device: Transdermal Vagus Nerve Stimulation (tVNS)

Nonstimulation

PLACEBO COMPARATOR

Placement of electrode without any stimulation.

Device: Transdermal Vagus Nerve Stimulation (tVNS)

Interventions

Transdermal Vagus Nerve Stimulation (tVNS) DEVICE

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.

Active Stimulation 0.5; Lobe Control; Nonstimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, 18 years of age or older.

You may not qualify if:

• self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine

Sponsors & Collaborators

• Arkansas Tech University: lead

Study Sites (1)

Arkansas Tech University

Russellville, Arkansas, 72801, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)