N/A
N=44
Understanding the Effects of Transauricular Vagus Nerve Stimulation on Neural Networks and Autonomic Nervous System
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05801809 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Resting-state Electroencephalogram (EEG) — 0.016; -0.025 Difference in alpha asymmetry (µV²).
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transauricular vagus nerve stimulation (taVNS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting-state Electroencephalogram (EEG) |
0.016; -0.025 | — |
| PRIMARY Conditioned Pain Modulation (CPM) Response - Change in Pain Ratings on the Pain-6 Scale (0-10) |
0.34; -0.53 | — |
| SECONDARY Heart Rate Variability (HRV) |
0.6; 0.1 | — |
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.
Eligibility Criteria
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).
- Uncontrolled epilepsy, as defined by previous clinical seizures in the past 3 months in patients with treatment for epilepsy.
- Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).
Data sourced from ClinicalTrials.gov (NCT05801809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.