Auricular Vagus Nerve Stimulation and Post-Stroke Dysphagia in Older Adults (SVA-DPA)

February 19, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
inactive device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (T0)
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.
T2, Day 3 ±2
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.
post-intervention (Day 22-24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
"voice change" sub-item from the GUSS assessment (binary variable: 0/1)This evaluates the presence or absence of voice changes after swallowing.
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)
Scores from the Swallowing Quality of Life Questionnaire (SWAL-QoL)
Baseline (T0) and post-intervention (T3, Day 22-24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Julien Poirier, MD, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

February 15, 2028

Study Completion (Estimated)

March 15, 2028

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-PP-22
  • Numéro ID RCB : 2025-A02819-40 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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