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

N/ANot Yet RecruitingNCT07428590

Centre Hospitalier Universitaire de Nice20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Dysphagia

Interventions

tVNS-E active deviceDEVICE

active device

tVNS-E inactive deviceDEVICE

inactive device

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 70 years. 2. Acute stroke (0-1 month post-stroke). 3. 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). 4. Ability to understand and follow experimental instructions. 5. Signed informed consent. 6. Participant covered by or beneficiary of a health insurance system.roke (0-1 month post-stroke) Exclusion Criteria: 1. Any associated medical condition preventing regular participation in rehabilitation activities at the time of inclusion. 2. Pre-existing dysphagia or dysphagia of non-stroke origin (e.g., myopathy, ENT cancer, laryngectomy). 3. Contraindications to vagus nerve stimulation (e.g., active epilepsy, active medical implants, severe cardiac pathology, severe uncontrolled psychiatric disorders). 4. GUSS swallowing test score \<5/20 at baseline. 5. Legal protection under guardianship or curatorship, or inability to participate in a clinical trial under French Public Health Code Article L.1121-16.

Locations (1)

CHU de Nice

Nice, France

Outcomes

Primary Outcomes

Change in swallowing function (Gugging Swallowing Screen, GUSS)

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

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

Involuntary cough during swallowing (GUSS sub-item)

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

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

Voice change during swallowing (GUSS sub-item)

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

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

Swallowing-related quality of life (SWAL-QoL)

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

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

Central Contacts

Julien Poirier, MD

CONTACT

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

Data from ClinicalTrials.gov

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