NCT06827301 Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
| NCT ID | NCT06827301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Campus Bio-Medico University |
| Condition | Dysphagia Following Cerebrovascular Accident |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-23 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-11-23 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06827301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphagia Following Cerebrovascular Accident. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06827301 currently recruiting?
Yes, NCT06827301 is actively recruiting participants. Contact the research team at f.capone@policlinicocampus.it for enrollment information.
Where is the NCT06827301 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06827301 clinical trial?
NCT06827301 is sponsored by Campus Bio-Medico University. The trial plans to enroll 30 participants.