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Recruiting NCT06827301

Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

No phase Interventional Dysphagia Following Cerebrovascular Accident

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non Invasive vagus nerve stimulation.
Who it may be relevant to
Registry conditions: Dysphagia Following Cerebrovascular Accident. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia

Overview

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).

Interventions

  • Device Non Invasive vagus nerve stimulation
    Transcutaneous Auricular Vagus Nerve Stimulation

Primary outcome measures

  • Swallowing function [Time frame: Baseline, Immediately after intervention]
Secondary outcome measures (4)
  • Disability [Time frame: Baseline, Immediately after intervention, 3 months after intervention]
  • Mortality [Time frame: Baseline, Immediately after intervention, 3 months after intervention]
  • Morbidity [Time frame: Baseline, Immediately after intervention, 3 months after intervention]
  • Swallowing function [Time frame: Baseline, 3 months after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Università Campus Bio-Medico di Roma — Roma

Publications

  • Capone F, Pilato F, Motolese F, Luccarelli V, Grattarola C, Selvaggi SA, Norata D, Rossi M, Todisco A, Celani LM, Marano M, Di Lazzaro V. Transcutaneous auricular vagus nerve stimulation for dysphagia in acute stroke: a randomized sham-controlled trial. Brain Stimul. 2026 Jul-Aug;19(4):103137. doi: 10.1016/j.brs.2026.103137. Epub 2026 Jun 2. PMID 42229578

Identifiers

NCT: NCT06827301 · LOGIC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗