Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
Campus Bio-Medico University
30 participants
Nov 23, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria2
- Acute ischemic or hemorrhagic stroke (within 7 days of onset)
- Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5
Exclusion Criteria2
- Pre-existing stroke dysphagia
- Dementia or other medical conditions that may interfere with the study
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Transcutaneous Auricular Vagus Nerve Stimulation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06827301