CompletedNot Applicable

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

United States44 participantsStarted 2023-04-26

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Able to provide informed consent to participate in the study.
✓. Subject is older than 18 years.
✓. Subjects should be naive to the stimulation (taVNS)

Exclusion criteria

✕. Pregnancy.
✕. 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.
✕. History of alcohol or drug abuse within the past 6 months as self-reported.
✕. Presence of the following contraindication to transauricular vagus nerve stimulation
✕. Ferromagnetic metal in the head and in the cranium (e.g., plates or pins, bullets, shrapnel)
✕. Implanted cranial electronic medical devices (e.g., cochlear implants)
✕. Implanted cardiac devices (e.g., pacemaker)
✕. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease).

What they're measuring

Resting-state Electroencephalogram (EEG)

Timeframe: Change from baseline to 60 minutes post-intervention.

Conditioned Pain Modulation (CPM) Response - Change in Pain Ratings on the Pain-6 Scale (0-10)

Timeframe: Change from baseline to 60 minutes post-taVNS.

Trial details

NCT IDNCT05801809

SponsorSpaulding Rehabilitation Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-23

Results submitted2025-09-12

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