Chronic Stroke PatientsCOVAGNIRSNCT07282106
Effect of Transcutaneous Auricular Stimulation of the Vagus Nerve on Functional Connectivity in the Brain at Rest
A study testing Active taVNS arm in people with Chronic Stroke Patients, run by Clinique Les Trois Soleils at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke Patients
- What is being tested?
- Active taVNS arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2025to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- age 18 or older
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- Right-handed participant;
- Participant who has agreed to sign an informed consent form;
- Participant who is affiliated with social security.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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:
Read more
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.
- Conditions
- Chronic Stroke Patients
- Being tested
- Active taVNS arm, Sham Control arm
- Keywords
- fNIRS, taVNS, stroke, functional brain connectivity, resting state, healthy people
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNS armDevice
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 armDevice
Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS arm | Experimental | 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. Receives: Device: Active taVNS arm |
| Sham Control arm | Sham comparator | Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition. Receives: Device: Sham Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-State Functional Connectivity
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start8 Dec 2025
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Les Trois Soleils
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282106
- Sponsor's protocol ID
- 2025-A01694-45
- Other IDs
- 25.03521.000408
- Acronym
- COVAGNIRS
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07282106
- Acronym / sponsor ID
- COVAGNIRS / 2025-A01694-45
- Conditions
- Chronic Stroke Patients
- Keywords
- fNIRS, taVNS, stroke, functional brain connectivity, resting state, healthy people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Clinique Les Trois SoleilsUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS arm | Experimental | Device: Active taVNS armTranscutaneous 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 | Sham comparator | Device: Sham Control armSimulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active taVNS armTranscutaneous 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 |
| Sham Control armSimulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition. | Device | Sham Control arm |
Primary outcome
Resting-State Functional Connectivity
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active taVNS arm in people with Chronic Stroke Patients, run by Clinique Les Trois Soleils at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting-State Functional Connectivity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.