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
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 20 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standard speech therapy combined with active tVNS-E stimulation (tVNS-E device switch on)
Device: tVNS-E active device
Participants will receive standard speech therapy combined with an inactive tVNS-E device (tVNS-E device switch of)
Device: tVNS-E inactive device
active device
inactive device
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)
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)
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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