Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

Condition(s) studied

Investigational drug(s) / intervention(s)

Non Invasive vagus nerve stimulation: Transcutaneous Auricular Vagus Nerve Stimulation

Study 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

Primary outcome measure(s)

• Swallowing function — Baseline, Immediately after intervention
  Swallowing video fluoroscopic will be used to measure swallowing function

Trial sites (1)

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