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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07282106

Acronym

COVAGNIRS

Enrollment

Registered

2025-12-15

Start date

2025-12-08

Completion date

2026-02-05

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke Patients

Keywords

fNIRS, taVNS, stroke, functional brain connectivity, resting state, healthy people

Brief summary

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.

Interventions

DEVICEActive 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.

DEVICESham Control arm

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Resting-State Functional Connectivity	Day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026