StrokeSVA-DPANCT07428590
Auricular Vagus Nerve Stimulation and Post-Stroke Dysphagia in Older Adults
A study testing tVNS-E active device and tVNS-E inactive device in people with Stroke and Dysphagia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- What is being tested?
- tVNS-E active device and tVNS-E inactive device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2026to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- tVNS-E active device, tVNS-E inactive device
- Keywords
- Vagus nerve stimulation, Aged, Stroke, Neuromodulation, Speech therapy, Deglutition disorders / rehabilitation
- Medical subject headings
- Stroke, Deglutition Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNS-E active deviceDevice
active device
tVNS-E inactive deviceDevice
inactive device
| Study group | Role | What they receive |
|---|---|---|
| active tVNS-E stimulation | Experimental | Participants will receive standard speech therapy combined with active tVNS-E stimulation (tVNS-E device switch on) Receives: 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) Receives: Device: tVNS-E inactive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in swallowing function (Gugging Swallowing Screen, GUSS)
comparison of total GUSS scores (ranging from 5 to 20) Higher scores indicate better swallowing function
Measured: 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.
Measured: 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.
Measured: post-intervention (Day 22-24)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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)
Measured: Baseline (T0) and post-intervention (T3, Day 22-24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Feb 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Poirier, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428590
- Sponsor's protocol ID
- 25-PP-22
- Other IDs
- Numéro ID RCB : 2025-A02819-40
- Acronym
- SVA-DPA
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07428590
- Acronym / sponsor ID
- SVA-DPA / 25-PP-22
- Keywords
- Vagus nerve stimulation, Aged, Stroke, Neuromodulation, Speech therapy, Deglutition disorders / rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| active tVNS-E stimulation | Experimental | Device: tVNS-E active deviceParticipants will receive standard speech therapy combined with active tVNS-E stimulation (tVNS-E device switch on) |
| inactive tVNS-E device | Sham comparator | Device: tVNS-E inactive deviceParticipants will receive standard speech therapy combined with an inactive tVNS-E device (tVNS-E device switch of) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVNS-E active deviceactive device | Device | active tVNS-E stimulation |
| tVNS-E inactive deviceinactive device | Device | inactive tVNS-E device |
Primary outcome
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
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.
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien Poirier, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS-E active device and tVNS-E inactive device in people with Stroke and Dysphagia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien Poirier, MD (04 92 03 49 11, poirier.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in swallowing function (Gugging Swallowing Screen, GUSS) (time frame: Baseline (T0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.