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NCT06827301Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
2 Dec 2024
Start date
23 Nov 2024
Primary completion date
Dec 2025
Lead sponsor
Campus Bio-Medico University
Diseases
Stroke
NCT number
NCT06827301

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 23 Nov 2024 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Università Campus Bio-Medico di Roma
Coordinator of this site? Confirm its status
RomaItalyRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.