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| ID | Type | Description | Link |
|---|---|---|---|
| Numéro ID RCB : 2025-A02819-40 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tVNS-E stimulation | Experimental | Participants will receive standard speech therapy combined with active tVNS-E stimulation (tVNS-E device switch on) |
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| inactive tVNS-E device | Sham Comparator | Participants will receive standard speech therapy combined with an inactive tVNS-E device (tVNS-E device switch of) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tVNS-E active device | Device | active device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in swallowing function (Gugging Swallowing Screen, GUSS) | comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function | Baseline (T0) |
| Change in swallowing function (Gugging Swallowing Screen, GUSS) | comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function. | T2, Day 3 ±2 |
| Change in swallowing function (Gugging Swallowing Screen, GUSS) | comparison of total GUSS scores (ranging from 5 to 20) across the study. Higher scores indicate better swallowing function. | post-intervention (Day 22-24) |
| Measure | Description | Time Frame |
|---|---|---|
| Involuntary cough during swallowing (GUSS sub-item) | "involuntary cough" sub-item from the GUSS assessment (binary variable: 0/1). This evaluates the presence or absence of involuntary coughing during swallowing. | Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24) |
| Voice change during swallowing (GUSS sub-item) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien Poirier, MD | Contact | 04 92 03 49 11 | poirier.j@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julien Poirier, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Nice | 06000 | France |
|
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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Participants do not know if the device is switch on or of
| tVNS-E inactive device |
| Device |
inactive device |
|
"voice change" sub-item from the GUSS assessment (binary variable: 0/1)This evaluates the presence or absence of voice changes after swallowing. |
| Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24) |
| Swallowing-related quality of life (SWAL-QoL) | Scores from the Swallowing Quality of Life Questionnaire (SWAL-QoL) | Baseline (T0) and post-intervention (T3, Day 22-24) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |