NCT06827301

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dysphagia Following Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	Non Invasive vagus nerve stimulation	Transcutaneous Auricular Vagus Nerve Stimulation

Timeline

• Start date: 2024-11-23
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2025-02-14
• Last updated: 2025-02-14

Locations

1 site across 1 country: Italy