CompletedNot Applicable

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

France84 participantsStarted 2025-12-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Resting-State Functional Connectivity

Timeframe: Day 1

Trial details

NCT IDNCT07282106

SponsorClinique Les Trois Soleils

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-05

View on ClinicalTrials.gov More Chronic Stroke Patients trials