Transcutaneous Auricular Vagus Nerve Stimulation for Treating 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).

NCT Number	NCT06827301
Lead Sponsor	Campus Bio-Medico University
Conditions	Dysphagia Following Cerebrovascular Accident
Enrollment	30 participants
Start Date	2024-11-23
Primary Completion	2025-12 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-02-14