Effect of (TaVNS) on Anxiety and Brain Function in Distressed Health Care Workers

NAActive, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

November 20, 2025

Study Completion Date

November 20, 2025

Conditions
AnxietyDistress, EmotionalEffects of VibrationHealthy
Interventions
OTHER

Neuvana 2.0 Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS)

The intervention administered is the TaVNS program and the fMRI scans to evaluate changes in the brain. The TaVNS program consists of placing ear buds from the device into each ear. They are initially sprayed once with a small amount of saline that is also provided as part of the TaVNS materials. Once the ear buds are placed in each ear, the test subject will start a preprogramed session of vibrations that will stimulate the vagus nerve. The session will last for 15 minutes and then the subject will take the ear buds out and clean them. They will use the TaVNS program once a day for 3 months.

OTHER

Waitlist Control

Baseline imaging and follow up imaging for comparison to the TaVNS health device group at approximately 3 months. The TaVNS intervention is offered after completion of the imaging.

OTHER

Healthy Controls: Substudy Group III

fMRI Imaging to evaluate the effects of the functional changes that may occur in the brain while using the TaVNS device during one fMRI session.

OTHER

Distressed Workers: Subgroup II

Subgroup II of 10 subjects with distress(all receiving TaVNS) will undergo fMRI scans with the TaVNS system being turned on and off while in the scanner to observe for any immediate effects and to evaluate the effects of the functional changes that may occur in the brain while using the TaVNS device during one fMRI session.

Trial Locations (1)

19107

Thomas Jefferson University, Marcus Institute of Integrative Health Centers, Philadelphia

All Listed Sponsors
lead

Thomas Jefferson University

OTHER