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
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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RECRUITING
NA
84 participants
INTERVENTIONAL
2025-12-08
2026-02-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
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.
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.
Sham Control arm
Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.
Sham Control arm
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.
Sham Control arm
Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Clinique Les Trois Soleils
OTHER
Responsible Party
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Locations
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Clinique Les Trois Soleils
Boissise-le-Roi, , France
Countries
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Central Contacts
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Facility Contacts
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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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