Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Dysphagia Following Cerebrovascular Accident

In brief

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).

Key facts

Study ID

NCT06827301

Run by

Campus Bio-Medico University

People needed

30

Starts

2024-11-23

Expected to finish

2026-06-01

Last updated by the study team

2025-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• Pre-existing stroke dysphagia
• Dementia or other medical conditions that may interfere with the study

Where it is running

• Università Campus Bio-Medico di Roma — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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