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NCT Number: NCT06827301

Transcutaneous Auricular Vagus Nerve Stimulation for Treating 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).

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Key information

Conditions

Dysphagia Following Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Campus Bio-Medico di Roma

Roma, RM, 00128, Italy

Location status: Recruiting

Location contact

Chiara Grattarola

SUB_INVESTIGATOR

Davide Norata, MD

SUB_INVESTIGATOR

Fabio Pilato, MD

SUB_INVESTIGATOR

Fioravante Capone, PhD

PRINCIPAL_INVESTIGATOR

Vincenzo Di Lazzaro

CONTACT

[email protected]

+3906225411220

Vitaliana Luccarelli

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non Invasive vagus nerve stimulation

Device

Transcutaneous Auricular Vagus Nerve Stimulation

Primary outcomes

  1. Swallowing function

    Time frame: Baseline, Immediately after intervention

    Swallowing video fluoroscopic will be used to measure swallowing function

Secondary outcomes

  1. Disability

    Time frame: Baseline, Immediately after intervention, 3 months after intervention

    Disability will be measured by mRS and the necessity of nasogastric tube/gastrostomy.

  2. Mortality

    Time frame: Baseline, Immediately after intervention, 3 months after intervention

    Number of deaths

  3. Morbidity

    Time frame: Baseline, Immediately after intervention, 3 months after intervention

    Number of aspiration pneumonia

  4. Swallowing function

    Time frame: Baseline, 3 months after intervention

    Swallowing video fluoroscopic will be used to measure swallowing function

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Pilato, MD

CONTACT

[email protected]

Fioravante Capone, PhD

CONTACT

[email protected]

06225411220

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Acronym: LOGIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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