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Not yet recruitingNCT07428590SVA-DPAUpdated Feb 24, 2026

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

An interventional study of tVNS-E active device and tVNS-E inactive device in Stroke and Dysphagia, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Dysphagia

Keywords

  • Vagus nerve stimulation
  • Aged
  • Stroke
  • Neuromodulation
  • Speech therapy
  • Deglutition disorders / rehabilitation
03

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    active tVNS-E stimulation

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

    Device: tVNS-E active device

  • Sham comparator
    inactive tVNS-E device

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

    Device: tVNS-E inactive device

Interventions

  • DevicetVNS-E active device

    active device

  • DevicetVNS-E inactive device

    inactive device

05

What researchers measure

Primary outcomes

  1. 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)

  2. 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

  3. 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

  1. 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)

  2. 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)

  3. 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)

06

Study locations

1 site
07

Registry details

Key details

Study ID
NCT07428590
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Feb 24, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
Feb 15, 2028 (estimated)
Completion
Mar 15, 2028 (estimated)
Last update
Feb 24, 2026

Study contacts

Julien Poirier, MD
Contact
poirier.j@chu-nice.fr
04 92 03 49 11
Julien Poirier, MD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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