Exploring the effects of transauricular vagus nerve stimulation on the nervous system
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
This study is testing how a new type of nerve stimulation affects the nervous system in healthy people to better understand its effects and safety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT05801809 on ClinicalTrials.gov |
What this trial studies
This trial investigates the physiological effects of a single session of transauricular vagus nerve stimulation (taVNS) in healthy participants through a randomized double-blind sham-control design. The study aims to assess how taVNS influences neural networks and autonomic function by measuring EEG metrics and heart rate variability (HRV). Additionally, it seeks to identify predictors that may affect individual responses to taVNS, which could inform the design of future clinical trials. The overall goal is to enhance understanding of taVNS's mechanisms and safety.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults over the age of 18 who have not previously experienced taVNS.
Not a fit: Patients with a history of neuropsychiatric or cardiac disorders, or those with contraindications to taVNS, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the mechanisms of taVNS, potentially leading to improved treatments for various neurological and psychiatric conditions.
How similar studies have performed: While several studies have shown promising results for taVNS in treating various disorders, this specific mechanistic approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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) Exclusion Criteria: 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).
Where this trial is running
Cambridge, Massachusetts
- Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Felipe Fregni, MD, PhD, MPH — Spaulding Rehabilitation Hospital/Harvard Medical School
- Study coordinator: Elly Pichardo, MD, PhD, MPH
- Email: epichardo@partners.org
- Phone: 6179526158
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.