← Back to Search

Device

taVNS Effects on Neural Networks in Healthy Subjects

N/A
Recruiting
Led By Felipe Fregni, MD, PhD, MPH
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline hrv at 60 minutes.
Awards & highlights

Study Summary

This trial study will look at the effects of stimulating certain nerves in the neck to see how it affects the body's neural networks and autonomic function.

Who is the study for?
This trial is for healthy adults over 18 who have never tried transauricular vagus nerve stimulation (taVNS) and can consent to participate. It's not for pregnant individuals, those with recent neuropsychiatric or cardiac disorders, metal in the head, implanted medical devices, uncontrolled health conditions like diabetes or epilepsy, or a history of substance abuse.Check my eligibility
What is being tested?
The study is testing how a single 60-minute session of taVNS affects brain networks and body regulation systems in healthy people. Participants are randomly assigned to receive either real taVNS or a sham (fake) treatment without knowing which one they get.See study design
What are the potential side effects?
Since this trial involves healthy subjects and non-invasive stimulation, side effects might be minimal but could include discomfort at the stimulation site or mild headaches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline qst at 60 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline qst at 60 minutes. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electroencephalogram (EEG) event-related potentials
Quantitative sensory testing (QST)
Resting-state electroencephalogram (EEG)
Secondary outcome measures
Heart rate variability (HRV)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active taVNSExperimental Treatment1 Intervention
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
Group II: Sham taVNSPlacebo Group1 Intervention
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
135 Previous Clinical Trials
11,011 Total Patients Enrolled
Felipe Fregni, MD, PhD, MPHPrincipal InvestigatorSpaulding Rehabilitation Hospital/Harvard Medical School
13 Previous Clinical Trials
564 Total Patients Enrolled

Media Library

Transauricular vagus nerve stimulation (taVNS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05801809 — N/A
Healthy Subjects Research Study Groups: Active taVNS, Sham taVNS
Healthy Subjects Clinical Trial 2023: Transauricular vagus nerve stimulation (taVNS) Highlights & Side Effects. Trial Name: NCT05801809 — N/A
Transauricular vagus nerve stimulation (taVNS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05801809 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for volunteers to join this clinical experiment?

"This research endeavour, posted to clinicaltrials.gov on April 1st 2023 and last edited on March 24th 2023, is no longer open for new enrollees. Nonetheless, 805 other trials are still actively recruiting patients."

Answered by AI

Does the current research encompass individuals over sixty years of age?

"This trial is looking for patients who are of age and no older than 99."

Answered by AI

Are there any qualifications that would make me eligible to participate in this experiment?

"To qualify for this trial, the potential patients must be in good health and aged between 18 to 99. Approximately 44 individuals are being recruited at present."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Spaulding Hospital Cambridge
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Understanding the Effects of Transauricular Vagus Nerve Stimulationon on Neural Networks and Autonomic Nervous System
Felipe Fregni, MD, PhD, MPH 2023. "Understanding the Effects of Transauricular Vagus Nerve Stimulationon on Neural Networks and Autonomic Nervous System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05801809.
~22 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top