Understanding the Effects of Transauricular Vagus Nerve Stimulationon on Neural Networks and Autonomic Nervous System

Description

This trial aims to perform an exploratory, mechanistic, randomized double-blind sham-control trial in healthy participants to assess the physiologic effects of a single 60 minutes session of bilateral taVNS, on neural networks and autonomic function.

Conditions

Healthy Volunteers

Talk to us

Study Overview

On this page

Study Details

Study overview

This trial aims to perform an exploratory, mechanistic, randomized double-blind sham-control trial in healthy participants to assess the physiologic effects of a single 60 minutes session of bilateral taVNS, on neural networks and autonomic function.

Understanding the Effects of Non-invasive Transauricular Vagus Nerve Stimulation (taVNS) on Neural Networks and Autonomic Nervous System: a Randomized Double-blind Sham-control Mechanistic Trial in Healthy Participants

Understanding the Effects of Transauricular Vagus Nerve Stimulationon on Neural Networks and Autonomic Nervous System

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Cambridge

Spaulding Hospital Cambridge, Cambridge, Massachusetts, United States, 02138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Able to provide informed consent to participate in the study.
  • 2. Subject is older than 18 years.
  • 3. Subjects should be naive to the stimulation (taVNS)
  • 1. Pregnancy.
  • 2. Subjects who have had a neuropsychiatric or a cardiac disorder diagnosis and have received treatment and chronic medication in the past six months, or who have functional deficits as a result.
  • 3. History of alcohol or drug abuse within the past 6 months as self-reported.
  • 4. Presence of the following contraindication to transauricular vagus nerve stimulation
  • 1. Ferromagnetic metal in the head and in the cranium (e.g., plates or pins, bullets, shrapnel)
  • 2. Implanted cranial electronic medical devices (e.g., cochlear implants)
  • 3. Implanted cardiac devices (e.g., pacemaker)
  • 5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease).
  • 6. Uncontrolled epilepsy, as defined by previous clinical seizures in the past 3 months in patients with treatment for epilepsy.
  • 7. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Spaulding Rehabilitation Hospital,

Felipe Fregni, MD, PhD, MPH, PRINCIPAL_INVESTIGATOR, Spaulding Rehabilitation Hospital/Harvard Medical School

Study Record Dates

2025-03-01