Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

Not Applicable

Recruiting

• Conditions: Dysphagia Following Cerebrovascular Accident

• Registration Number: NCT06827301
• Lead Sponsor: Campus Bio-Medico University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-23
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Swallowing function	Baseline, Immediately after intervention	Swallowing video fluoroscopic will be used to measure swallowing function

Secondary Outcome Measures

Name	Time	Method
Morbidity	Baseline, Immediately after intervention, 3 months after intervention	Number of aspiration pneumonia
Disability	Baseline, Immediately after intervention, 3 months after intervention	Disability will be measured by mRS and the necessity of nasogastric tube/gastrostomy.
Swallowing function	Baseline, 3 months after intervention	Swallowing video fluoroscopic will be used to measure swallowing function
Mortality	Baseline, Immediately after intervention, 3 months after intervention	Number of deaths

Trial Locations

Locations (1)

Università Campus Bio-Medico di Roma; 🇮🇹 Roma, RM, Italy