Auricular Vagus Nerve Stimulation and Post-Stroke Dysphagia in Older Adults (NCT07428590) | Clinical Trial Compass
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 range
70 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in swallowing function (Gugging Swallowing Screen, GUSS)
Timeframe: Baseline (T0)
2
Change in swallowing function (Gugging Swallowing Screen, GUSS)
Timeframe: T2, Day 3 ±2
3
Change in swallowing function (Gugging Swallowing Screen, GUSS)
. 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.