Auricular Vagus Nerve Stimulation and Post-Stroke Dysphagia in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tVNS-E active device, tVNS-E inactive device.
- Who it may be relevant to
- Registry conditions: Stroke, Dysphagia. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Non-Invasive Auricular Vagus Nerve Stimulation on the Rehabilitation of Pharyngo-Laryngeal Dysphagia in Patients Over 70 Years Old After Stroke
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.
Interventions
- Device tVNS-E active device
active device - Device tVNS-E inactive device
inactive device
Primary outcome measures
- Change in swallowing function (Gugging Swallowing Screen, GUSS) [Time frame: Baseline (T0)]
- Change in swallowing function (Gugging Swallowing Screen, GUSS) [Time frame: T2, Day 3 ±2]
- Change in swallowing function (Gugging Swallowing Screen, GUSS) [Time frame: post-intervention (Day 22-24)]
Secondary outcome measures (3)
- Involuntary cough during swallowing (GUSS sub-item) [Time frame: Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24)]
- Voice change during swallowing (GUSS sub-item) [Time frame: Baseline (T0), mid-protocol (T2, Day 3 ±2), post-intervention (T3, Day 22-24)]
- Swallowing-related quality of life (SWAL-QoL) [Time frame: Baseline (T0) and post-intervention (T3, Day 22-24)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT07428590 · 25-PP-22 · Numéro ID RCB : 2025-A02819-40