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: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
Clinique Les Trois Soleils
RECRUITING
Boissise-le-roi
Contact Information
Primary
Christophe DURET, MD
ch.duret@les-trois-soleils.fr
+33164718000
Time Frame
Start Date: 2025-12-08
Estimated Completion Date: 2026-02-06
Participants
Target number of participants: 84
Treatments
Experimental: 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_comparator: Sham Control arm
Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.
Related Therapeutic Areas
Sponsors
Leads: Clinique Les Trois Soleils

This content was sourced from clinicaltrials.gov