Not Yet RecruitingNot Applicable

Auricular Vagus Nerve Stimulation and Post-Stroke Dysphagia in Older Adults

France20 participantsStarted 2026-03-15

Plain-language summary

This study investigates the effect of non-invasive transcutaneous auricular vagus nerve stimulation (tVNS-E) on swallowing rehabilitation in patients over 70 years old after stroke. Participants will be randomly assigned to standard speech therapy with either active tVNS-E or a sham device, over four sessions per week for three weeks. Swallowing function and quality of life will be assessed before and after the intervention to evaluate the potential benefit of tVNS-E.

Who can participate

Age range70 Years

SexALL

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

✓. Age ≥ 70 years.
✓. Acute stroke (0-1 month post-stroke).
✓. Pharyngo-laryngeal dysphagia (Gugging Swallowing Screen, GUSS: 5/5 on preliminary test and \<4/5 on direct test, ignoring the drooling criterion which is not indicative of pharyngo-laryngeal dysphagia).
✓. Ability to understand and follow experimental instructions.
✓. Signed informed consent.
✓. Participant covered by or beneficiary of a health insurance system.roke (0-1 month post-stroke)

Exclusion criteria

✕. Any associated medical condition preventing regular participation in rehabilitation activities at the time of inclusion.
✕. Pre-existing dysphagia or dysphagia of non-stroke origin (e.g., myopathy, ENT cancer, laryngectomy).
✕. Contraindications to vagus nerve stimulation (e.g., active epilepsy, active medical implants, severe cardiac pathology, severe uncontrolled psychiatric disorders).
✕. GUSS swallowing test score \<5/20 at baseline.
✕. Legal protection under guardianship or curatorship, or inability to participate in a clinical trial under French Public Health Code Article L.1121-16.

What they're measuring

Change in swallowing function (Gugging Swallowing Screen, GUSS)

Timeframe: Baseline (T0)

Change in swallowing function (Gugging Swallowing Screen, GUSS)

Timeframe: T2, Day 3 ±2

Change in swallowing function (Gugging Swallowing Screen, GUSS)

Timeframe: post-intervention (Day 22-24)

Trial details

NCT IDNCT07428590

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-15

Contact for this trial

Julien Poirier, MD

04 92 03 49 11 poirier.j@chu-nice.fr

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range70 Years

SexALL

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

✓. Age ≥ 70 years.
✓. Acute stroke (0-1 month post-stroke).
✓. Pharyngo-laryngeal dysphagia (Gugging Swallowing Screen, GUSS: 5/5 on preliminary test and \<4/5 on direct test, ignoring the drooling criterion which is not indicative of pharyngo-laryngeal dysphagia).
✓. Ability to understand and follow experimental instructions.
✓. Signed informed consent.
✓. Participant covered by or beneficiary of a health insurance system.roke (0-1 month post-stroke)

Exclusion criteria

✕. Any associated medical condition preventing regular participation in rehabilitation activities at the time of inclusion.
✕. Pre-existing dysphagia or dysphagia of non-stroke origin (e.g., myopathy, ENT cancer, laryngectomy).
✕. Contraindications to vagus nerve stimulation (e.g., active epilepsy, active medical implants, severe cardiac pathology, severe uncontrolled psychiatric disorders).
✕. GUSS swallowing test score \<5/20 at baseline.
✕. Legal protection under guardianship or curatorship, or inability to participate in a clinical trial under French Public Health Code Article L.1121-16.