Understanding the Effects of Transauricular Vagus Nerve Stimulation on Neural Networks and Autonomic Nervous System
Completed · Not applicable · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT05801809
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 44
- Starts
- 2023-04-26
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Able to provide informed consent to participate in the study.
- Subject is older than 18 years.
- Subjects should be naive to the stimulation (taVNS)
You may not qualify if…
- 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).
Where it is running
- Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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