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

Summary

The purpose of this research is to measure alterations in anxiety and brain activity associated with the use of an approved health device called Transauricular Vagal Nerve Stimulation (TaVNS) in distressed persons who work in a health care and distressed healthcare workers in the the Philadelphia, PA region. The Investigators will be using functional magnetic resonance imaging (or fMRI) to measure changes in each subject's brain function during the use of VNS. This study is designed to allow researchers to understand the changes in cerebral (brain) activity that occur when a subject uses VNS. Thus, the primary goal of the proposed study is to evaluate the ability of the TaVNS system to reduce distress and change neurophysiology among health care providers.

The Investigators, hypothesize that using the TaVNS device will help reduce distress in individuals.

In order to understand the mechanisms of change that occur while using the VNS study, the Investigators have added a substudy of participants who do not experience high levels of distress to evaluate the effects of the functional changes that may occur in the brain while using the TaVNS device.

In addition to the primary aims of the overalll study to assess distress in workers while enrolled in a TaVNS program, a subgroup of 50 subjects will undergo functional magnetic resonance imaging (fMRI) while using the VNS device to assess the changes in the brain including neurophysiological effects of TaVNS.

The goal of this substudy is to observe the changes in the brain while using the TaVNS earbuds in the MRI to increase our understanding of the mechanisms and processing involved while using TaVNS. In this substudy, which is amendment version 3.0, the investigators have increased the number of persons to include 50 subjects who will use the device in the MRI to evaluate the neural processes and cerebral blood flow while using TaVNS.

Conditions

• Anxiety
• Distress, Emotional
• Effects of Vibration
• Healthy

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.

Sponsors & Collaborators

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• Andrew B Newberg · Department of Integrative Medicine and Nutritional Sciences

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2025-11-20

Completion

2025-11-20

Countries

• United States

Study Locations