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Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

RecruitingNAAges 18 Years - anyAllCampus Bio-Medico University
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 criteria: * Pre-existing stroke dysphagia * Dementia or other medical conditions that may interfere with the study
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What it tests

  • Non Invasive vagus nerve stimulation
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Where

1 site
Universitร  Campus Bio-Medico di Roma
Roma, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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