Actively Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
Led by Campus Bio-Medico University · Updated on 2025-02-14
30
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Pre-existing stroke dysphagia
- Dementia or other medical conditions that may interfere with the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Università Campus Bio-Medico di Roma
Roma, RM, Italy, 00128
Actively Recruiting
Research Team
F
Fioravante Capone, PhD
CONTACT
F
Fabio Pilato, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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