Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

NCT06827301 | Recruiting

• 1 other identifier: LOGIC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Dysphagia Following Cerebrovascular Accident

Keywords

vagus nerve stimulation; dysphagia; stroke

Outcome Measures

Primary Outcomes (1)

• Swallowing function

  Swallowing video fluoroscopic will be used to measure swallowing function

  Baseline, Immediately after intervention

Secondary Outcomes (4)

• Disability

  Baseline, Immediately after intervention, 3 months after intervention

• Mortality

  Baseline, Immediately after intervention, 3 months after intervention

• Morbidity

  Baseline, Immediately after intervention, 3 months after intervention

• Swallowing function

  Baseline, 3 months after intervention

Study Arms (2)

Real t-VNS

EXPERIMENTAL

real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.

Device: Non Invasive vagus nerve stimulation

Sham t-VNS

ACTIVE COMPARATOR

sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.

Device: Non Invasive vagus nerve stimulation

Interventions

Non Invasive vagus nerve stimulation DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Real t-VNS; Sham t-VNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pre-existing stroke dysphagia
• Dementia or other medical conditions that may interfere with the study

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Università Campus Bio-Medico di Roma

Roma, RM, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Fioravante Capone, PhD

CONTACT

06225411220; f.capone@policlinicocampus.it

Fabio Pilato, MD

CONTACT

f.pilato@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: February 14, 2025
• Study Start: November 23, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-12

Locations

IT (1)