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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Università Campus Bio-Medico di Roma Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
Related publications
- Transcutaneous auricular vagus nerve stimulation for dysphagia in acute stroke: a randomized sham-controlled trial.Brain Stimul · 2026 · PMID 42229578
This page is information, not medical advice. Discuss any trial with your doctor.