RecruitingNot ApplicableNCT06827301

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


Sponsor

Campus Bio-Medico University

Enrollment

30 participants

Start Date

Nov 23, 2024

Study Type

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

Min Age: 18 Years

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

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Interventions

DEVICENon Invasive vagus nerve stimulation

Transcutaneous Auricular Vagus Nerve Stimulation


Locations(1)

Università Campus Bio-Medico di Roma

Roma, RM, Italy

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NCT06827301


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