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Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Università Campus Bio-Medico di Roma
Roma, RM, Italy
Start Date
November 23, 2024
Primary Completion Date
December 1, 2025
Completion Date
June 1, 2026
Last Updated
February 14, 2025
30
ESTIMATED participants
Non Invasive vagus nerve stimulation
DEVICE
Lead Sponsor
Campus Bio-Medico University
NCT06195501
NCT06692101
Data Source & Attribution
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