Non-invasive ear nerve stimulation with speech therapy for swallowing problems after stroke
Tests ear nerve stimulation with speech therapy in adults with swallowing trouble after stroke.
Plain-language title generated from the registry record
Registry title: Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Università Campus Bio-Medico di RomaRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Campus Bio-Medico University
- Trial code
- NCT06827301
- Record updated
- 14 February 2025
- Original description
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.Read full original descriptionShow less
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
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).
Inclusion: 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: Pre-existing stroke dysphagia; Dementia or other medical conditions that may interfere with the study.