Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia (LOGIC)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Dysphagia Following Cerebrovascular Accident
• Intervention / Treatment: Device: Non Invasive vagus nerve stimulation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fioravante Capone, PhD; Phone Number: 06225411220; Email: f.capone@policlinicocampus.it
• Study Contact Backup: Name: Fabio Pilato, MD; Email: f.pilato@policlinicocampus.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00128
      • Recruiting
      • Universita Campus Bio-Medico di Roma
      • Contact: Vincenzo Di Lazzaro; Phone Number: +3906225411220; Email: v.dilazzaro@unicampus.it
      • Contact: Fioravante Capone, PhD
      • Contact: Fabio Pilato, MD
      • Contact: Vitaliana Luccarelli
      • Contact: Chiara Grattarola
      • Contact: Davide Norata, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real t-VNS; real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.	Device: Non Invasive vagus nerve stimulation; Transcutaneous Auricular Vagus Nerve Stimulation
Active Comparator: Sham t-VNS; sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.	Device: Non Invasive vagus nerve stimulation; Transcutaneous Auricular Vagus Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing function	Swallowing video fluoroscopic will be used to measure swallowing function	Baseline, Immediately after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: stroke; vagus nerve stimulation; dysphagia
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: LOGIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No