Completed

NCT Number: NCT07282106

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

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.

Completed

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Key information

Conditions

Chronic Stroke Patients Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active taVNS arm

Device

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 Control arm

Device

Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.

Primary outcomes

Resting-State Functional Connectivity

Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Clinique Les Trois Soleils

Other

Registry information

Official study title

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

Acronym: COVAGNIRS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Dec 15, 2025
Registry last updated: Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed