Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Università Campus Bio-Medico di Roma
RECRUITING
Roma
Contact Information
Primary
Fioravante Capone, PhD
f.capone@policlinicocampus.it
06225411220
Backup
Fabio Pilato, MD
f.pilato@policlinicocampus.it
Time Frame
Start Date: 2024-11-23
Estimated Completion Date: 2026-06
Participants
Target number of participants: 30
Treatments
Experimental: Real t-VNS
real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.
Active_comparator: Sham t-VNS
sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.
Related Therapeutic Areas
Sponsors
Leads: Campus Bio-Medico University

This content was sourced from clinicaltrials.gov

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