Using vagus nerve stimulation to treat swallowing difficulties after a stroke
Official title: Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
Run by Campus Bio-Medico University · NCT06827301 · Data updated 2026-11-12
This study is testing if a new treatment using vagus nerve stimulation, along with speech therapy, can help people who have had a stroke improve their swallowing difficulties.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Campus Bio-Medico University Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | November 23, 2024 |
| Main results expected | December 2025 |
| Study ends | June 2026 |
| Registry record updated | February 14, 2025 |
| Trial ID | NCT06827301 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who have experienced an acute ischemic or hemorrhagic stroke within the last 7 days and have a diagnosed dysphagia severity score between 3 and 5.
✕Probably not a fit
Patients with pre-existing stroke dysphagia or those with dementia or other medical conditions that may interfere with the study will not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (t-VNS) combined with speech therapy in improving swallowing function in patients who have recently experienced a stroke. A total of 30 patients will be randomly assigned to receive either real t-VNS or a placebo, alongside daily speech therapy sessions for three consecutive days. The study will assess swallowing function and clinical conditions at baseline, immediately after the intervention, and three months later to determine the impact of the treatment.
Why it matters
Potential benefit: If successful, this approach could significantly improve swallowing function and reduce complications related to dysphagia in stroke patients.
How similar studies have gone: While the use of vagus nerve stimulation is a novel approach in this context, similar studies have shown promise in other applications of vagus nerve stimulation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Università Campus Bio-Medico di Roma
Roma, Rm, Italy Recruiting
Study contacts
- Study coordinator: Fioravante Capone, PhD
- Email: f.capone@policlinicocampus.it
- Phone: 06225411220
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.