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: * REAL: real t-VNS + speech therapy * SHAM: t-VNS placebo + speech therapy. The experimental treatment consists in the association between t-VNS (real or placebo) and speech therapy exercises to improve swallowing functionality. Each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-VNS on left ear. 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Transcutaneous Auricular Vagus Nerve Stimulation
Università Campus Bio-Medico di Roma
Roma, RM, Italy
RECRUITINGSwallowing function
Swallowing video fluoroscopic will be used to measure swallowing function
Time frame: Baseline, Immediately after intervention
Disability
Disability will be measured by mRS and the necessity of nasogastric tube/gastrostomy.
Time frame: Baseline, Immediately after intervention, 3 months after intervention
Mortality
Number of deaths
Time frame: Baseline, Immediately after intervention, 3 months after intervention
Morbidity
Number of aspiration pneumonia
Time frame: Baseline, Immediately after intervention, 3 months after intervention
Swallowing function
Swallowing video fluoroscopic will be used to measure swallowing function
Time frame: Baseline, 3 months after intervention
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