90
Participants
Start Date
April 1, 2021
Primary Completion Date
November 20, 2025
Study Completion Date
November 20, 2025
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.
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.
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.
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.
Thomas Jefferson University, Marcus Institute of Integrative Health Centers, Philadelphia
Thomas Jefferson University
OTHER