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

NCT ID: NCT05801809

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-26
• Study Completion Date: 2026-03-01

Brief 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.

Detailed Description

Several studies have shown promising results of taVNS to treat various disorders such as depression, anxiety, Alzheimer's disease, headache, obesity, and diabetes. However, no mechanistic studies have investigated the taVNS neural network and autonomic nervous system effects of this technique. Therefore, we aim to assess how taVNS can affect EEG metrics and HRV and assess its safety. Also, we aim to evaluate predictors that can influence the response to taVNS, so understanding the variables associated with response to taVNS can help the design of future clinical trials to maximize the effects of this intervention.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Active taVNS

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 Type: EXPERIMENTAL

Transauricular vagus nerve stimulation (taVNS)

Intervention Type: DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Sham taVNS

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.

Group Type: SHAM_COMPARATOR

Transauricular vagus nerve stimulation (taVNS)

Intervention Type: DEVICE

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Interventions

Transauricular vagus nerve stimulation (taVNS)

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni, MD, PhD, MPH

Director of Spaulding Neuromodulation Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital/Harvard Medical School

Locations

Spaulding Hospital Cambridge

Cambridge, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022P003200

Identifier Type: -

Identifier Source: org_study_id