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

NCT07428590 | Not Yet Recruiting

• 2 other identifiers: 25-PP-22Numéro ID RCB : 2025-A02819-40
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Dysphagia

Keywords

Vagus nerve stimulation; Aged; Stroke; Neuromodulation; Speech therapy; Deglutition disorders / rehabilitation

Outcome Measures

Primary Outcomes (3)

• Change in swallowing function (Gugging Swallowing Screen, GUSS)

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

  Baseline (T0)

• Change in swallowing function (Gugging Swallowing Screen, GUSS)

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

  T2, Day 3 ±2

• Change in swallowing function (Gugging Swallowing Screen, GUSS)

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

  post-intervention (Day 22-24)

Secondary Outcomes (3)

• Involuntary cough during swallowing (GUSS sub-item)

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

• Voice change during swallowing (GUSS sub-item)

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

• Swallowing-related quality of life (SWAL-QoL)

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

Study Arms (2)

active tVNS-E stimulation

EXPERIMENTAL

Participants will receive standard speech therapy combined with active tVNS-E stimulation (tVNS-E device switch on)

Device: tVNS-E active device

inactive tVNS-E device

SHAM COMPARATOR

Participants will receive standard speech therapy combined with an inactive tVNS-E device (tVNS-E device switch of)

Device: tVNS-E inactive device

Interventions

tVNS-E active device DEVICE

active device

active tVNS-E stimulation

tVNS-E inactive device DEVICE

inactive device

inactive tVNS-E device

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders; Communication Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Julien Poirier, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien Poirier, MD

CONTACT

04 92 03 49 11; poirier.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know if the device is switch on or of
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the experimental group receiving standard speech therapy combined with active tVNS-E stimulation, or the sham group receiving standard speech therapy with an inactive tVNS-E device.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FR (1)