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

NCT ID: NCT07282106

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2026-02-06

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Stroke Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Active taVNS arm

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Sham Control arm

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Sham Control arm

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
* Right-handed participant;
* Participant who has agreed to sign an informed consent form;
* Participant who is affiliated with social security.

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinique Les Trois Soleils

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Les Trois Soleils

Boissise-le-Roi, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christophe DURET, MD

Role: CONTACT

+33164718000

Facility Contacts

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Christophe DURET, MD

Role: primary

+33164718000

Other Identifiers

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25.03521.000408

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-A01694-45

Identifier Type: -

Identifier Source: org_study_id

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