Effect of Transcutaneous Auricular Stimulation of the Vagus Nerve on Functional Connectivity in the Brain at Rest (COVAGNIRS)

March 16, 2026 updated by: Clinique Les Trois Soleils

Effect of Transcutaneous Auricular Stimulation of the Vagus Nerve on Functional Connectivity in the Brain at Rest: fNIRS Study in Chronic Post-stroke Subjects and Healthy Subjects

The goal of this clinical trial is to study the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on resting-state brain functional connectivity. The study will assess this effect using functional Near-Infrared Spectroscopy (fNIRS) in both chronic post-stroke patients and healthy subjects.

The main questions it aims to answer are:

Does taVNS affect resting-state functional connectivity (measured by fNIRS) in chronic post-stroke patients?

Does taVNS affect resting-state functional connectivity (measured by fNIRS) in healthy subjects?

Are there differences in the effect of taVNS on functional connectivity between the post-stroke group and the healthy group?

Researchers will compare the effect of active taVNS (real stimulation) to a sham stimulation (control) to evaluate its specific impact on the brain's functional networks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boissise-le-Roi, France, 77310
        • Clinique Les Trois Soleils

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for post-stroke participant:

  • age 18 or older
  • Right-handed participant;
  • Hemiparesis in the chronic phase (>6 months post-stroke)
  • Participant who has agreed to sign an informed consent form;
  • Participant who is affiliated with social security.

Inclusion Criteria for healthy participant:

  • age 18 or older
  • Right-handed participant;
  • Participant who has agreed to sign an informed consent form;
  • Participant who is affiliated with social security.

Exclusion Criteria for post-stroke participant:

  • Allergy to neoprene (the material used to make the fNIRS cap);
  • Hair volume preventing the cap from being put on and/or access to the scalp;
  • Cognitive impairment making it impossible to participate in the study;
  • Phasic disorders preventing understanding of instructions and effective communication;
  • Pregnant or breastfeeding women;
  • Persons under legal protection

Exclusion Criteria for post-stroke participant:

  • Allergy to neoprene (the material used to make the fNIRS cap);
  • Hair volume preventing the cap from being put on and/or access to the scalp;
  • Pregnant or breastfeeding women;
  • Persons under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active taVNS arm
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Delivery of low-intensity electrical impulses to the outer ear (concha and tragus) to stimulate the auricular branch of the vagus nerve.
Device: Active taVNS arm
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Delivery of low-intensity electrical impulses to the outer ear (concha and tragus) to stimulate the auricular branch of the vagus nerve.
Sham Comparator: Sham Control arm
Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.
Device: Sham Control arm
Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resting-State Functional Connectivity
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Les Trois Soleils

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Actual)

February 5, 2026

Study Completion (Actual)

February 5, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01694-45
  • 25.03521.000408 (Registry Identifier: SI RIPH 2G)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Stroke Patients

Clinical Trials on Active taVNS arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe