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NCT Number: NCT07428590

Auricular Vagus Nerve Stimulation and Post-Stroke Dysphagia in Older Adults

This study investigates the effect of non-invasive transcutaneous auricular vagus nerve stimulation (tVNS-E) on swallowing rehabilitation in patients over 70 years old after stroke. Participants will be randomly assigned to standard speech therapy with either active tVNS-E or a sham device, over four sessions per week for three weeks. Swallowing function and quality of life will be assessed before and after the intervention to evaluate the potential benefit of tVNS-E.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

Location contact

Julien Poirier, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 70 years.
  • Acute stroke (0-1 month post-stroke).
  • Pharyngo-laryngeal dysphagia (Gugging Swallowing Screen, GUSS: 5/5 on preliminary test and <4/5 on direct test, ignoring the drooling criterion which is not indicative of pharyngo-laryngeal dysphagia).
  • Ability to understand and follow experimental instructions.
  • Signed informed consent.
  • Participant covered by or beneficiary of a health insurance system.roke (0-1 month post-stroke)

Exclusion criteria

  • Any associated medical condition preventing regular participation in rehabilitation activities at the time of inclusion.
  • Pre-existing dysphagia or dysphagia of non-stroke origin (e.g., myopathy, ENT cancer, laryngectomy).
  • Contraindications to vagus nerve stimulation (e.g., active epilepsy, active medical implants, severe cardiac pathology, severe uncontrolled psychiatric disorders).
  • GUSS swallowing test score <5/20 at baseline.
  • Legal protection under guardianship or curatorship, or inability to participate in a clinical trial under French Public Health Code Article L.1121-16.

Treatment and study plan

tVNS-E active device

Device

active device

tVNS-E inactive device

Device

inactive device

Primary outcomes

  1. Change in swallowing function (Gugging Swallowing Screen, GUSS)

    Time frame: Baseline (T0)

    comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function

  2. Change in swallowing function (Gugging Swallowing Screen, GUSS)

    Time frame: T2, Day 3 ±2

    comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function.

  3. Change in swallowing function (Gugging Swallowing Screen, GUSS)

    Time frame: post-intervention (Day 22-24)

    comparison of total GUSS scores (ranging from 5 to 20) across the study. Higher scores indicate better swallowing function.

Secondary outcomes

  1. Involuntary cough during swallowing (GUSS sub-item)

    Time frame: Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24)

    "involuntary cough" sub-item from the GUSS assessment (binary variable: 0/1). This evaluates the presence or absence of involuntary coughing during swallowing.

  2. Voice change during swallowing (GUSS sub-item)

    Time frame: Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24)

    "voice change" sub-item from the GUSS assessment (binary variable: 0/1)This evaluates the presence or absence of voice changes after swallowing.

  3. Swallowing-related quality of life (SWAL-QoL)

    Time frame: Baseline (T0) and post-intervention (T3, Day 22-24)

    Scores from the Swallowing Quality of Life Questionnaire (SWAL-QoL)

Study contacts

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

Julien Poirier, MD

CONTACT

[email protected]

04 92 03 49 11

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Effect of Non-Invasive Auricular Vagus Nerve Stimulation on the Rehabilitation of Pharyngo-Laryngeal Dysphagia in Patients Over 70 Years Old After Stroke

Acronym: SVA-DPA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

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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