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The aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-VNS) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition.
30 patients will be randomized into one of the two arms of the study:
Swallowing function and clinical conditions will be evaluated before the intervention (baseline, T0), immediately after the intervention (T1) and 3 months after the intervention (T2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real t-VNS | Experimental | real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy. |
|
| Sham t-VNS | Active Comparator | sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Invasive vagus nerve stimulation | Device | Transcutaneous Auricular Vagus Nerve Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing function | Swallowing video fluoroscopic will be used to measure swallowing function | Baseline, Immediately after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Disability will be measured by mRS and the necessity of nasogastric tube/gastrostomy. | Baseline, Immediately after intervention, 3 months after intervention |
| Mortality | Number of deaths |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fioravante Capone, PhD | Contact | 06225411220 | f.capone@policlinicocampus.it | |
| Fabio Pilato, MD | Contact | f.pilato@policlinicocampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Campus Bio-Medico di Roma | Recruiting | Roma | RM | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42229578 | Derived | Capone F, Pilato F, Motolese F, Luccarelli V, Grattarola C, Selvaggi SA, Norata D, Rossi M, Todisco A, Celani LM, Marano M, Di Lazzaro V. Transcutaneous auricular vagus nerve stimulation for dysphagia in acute stroke: a randomized sham-controlled trial. Brain Stimul. 2026 Jun 2;19(4):103137. doi: 10.1016/j.brs.2026.103137. Online ahead of print. |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Baseline, Immediately after intervention, 3 months after intervention |
| Morbidity | Number of aspiration pneumonia | Baseline, Immediately after intervention, 3 months after intervention |
| Swallowing function | Swallowing video fluoroscopic will be used to measure swallowing function | Baseline, 3 months after intervention |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |