Auricular Vagus Nerve Stimulation and Post-Stroke Dysphagia in Older Adults
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Study ID
- NCT07428590
- Status
- Not Yet Recruiting
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Conditions
- Dysphagia
- Stroke
Eligibility Criteria
- Sex
- ALL
- Age
- 70 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- tVNS-E active device — DEVICEactive device
- tVNS-E inactive device — DEVICEinactive device
Study Details
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.
Key Dates
- First listed
- Feb 24, 2026
- Start date
- Mar 15, 2026
- Status verified
- Feb 2026
- Primary completion
- Feb 15, 2028
- Completion
- Mar 15, 2028
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: active tVNS-E stimulationParticipants will receive standard speech therapy combined with active tVNS-E stimulation (tVNS-E device switch on)
- Sham Comparator: inactive tVNS-E deviceParticipants will receive standard speech therapy combined with an inactive tVNS-E device (tVNS-E device switch of)
Primary Outcome Measure
Change in swallowing function (Gugging Swallowing Screen, GUSS) [ Time Frame: Baseline (T0) ]
Central Contacts
- Julien Poirier, MD04 92 03 49 11
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