Dysphagia, Stroke
Conditions
Keywords
Vagus nerve stimulation, Aged, Stroke, Neuromodulation, Speech therapy, Deglutition disorders / rehabilitation
Brief 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.
Interventions
DEVICEtVNS-E active device
active device
DEVICEtVNS-E inactive device
inactive device
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants do not know if the device is switch on or of
Intervention model description
Participants are randomly assigned to either the experimental group receiving standard speech therapy combined with active tVNS-E stimulation, or the sham group receiving standard speech therapy with an inactive tVNS-E device.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 70 years. 2. Acute stroke (0-1 month post-stroke). 3. 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). 4. Ability to understand and follow experimental instructions. 5. Signed informed consent. 6. Participant covered by or beneficiary of a health insurance system.roke (0-1 month post-stroke)
Exclusion criteria
1. Any associated medical condition preventing regular participation in rehabilitation activities at the time of inclusion. 2. Pre-existing dysphagia or dysphagia of non-stroke origin (e.g., myopathy, ENT cancer, laryngectomy). 3. Contraindications to vagus nerve stimulation (e.g., active epilepsy, active medical implants, severe cardiac pathology, severe uncontrolled psychiatric disorders). 4. GUSS swallowing test score \<5/20 at baseline. 5. Legal protection under guardianship or curatorship, or inability to participate in a clinical trial under French Public Health Code Article L.1121-16.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in swallowing function (Gugging Swallowing Screen, GUSS) | Baseline (T0) | comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Involuntary cough during swallowing (GUSS sub-item) | Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24) | "involuntary cough" sub-item from the GUSS assessment (binary variable: 0/1). This evaluates the presence or absence of involuntary coughing during swallowing. |
| Voice change during swallowing (GUSS sub-item) | Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24) | "voice change" sub-item from the GUSS assessment (binary variable: 0/1)This evaluates the presence or absence of voice changes after swallowing. |
| Swallowing-related quality of life (SWAL-QoL) | Baseline (T0) and post-intervention (T3, Day 22-24) | Scores from the Swallowing Quality of Life Questionnaire (SWAL-QoL) |
Countries
France
Contacts
CONTACTJulien Poirier, MD
PRINCIPAL_INVESTIGATORJulien Poirier, MD
Centre Hospitalier Universitaire de Nice
Outcome results
None listed