Mechanisms of Air-pulse Pharyngeal Sensory Stimulation Regulation Post-stroke Swallowing Neural Network Remodeling Via TRPV4 Channel
20 août 2026 mis à jour par: Zhiming Tang, First People's Hospital of Foshan
This randomized, double-blind, sham-controlled clinical trial will investigate the effects and potential neural mechanisms of pharyngeal air-pulse sensory stimulation in patients with post-stroke dysphagia. A total of 80 participants with swallowing impairment after stroke will be randomly assigned in a 1:1 ratio to either an active stimulation group or a sham stimulation group. Both groups will receive conventional swallowing rehabilitation, while the active group will additionally receive pharyngeal air-pulse sensory stimulation and the control group will receive sham stimulation for 2 weeks.
Swallowing function and neurophysiological changes will be assessed before and after the intervention. Assessments will include clinical swallowing evaluations, videofluoroscopic swallowing study, surface electromyography, resting-state and task-based functional magnetic resonance imaging, and diffusion kurtosis imaging. The study aims to determine whether pharyngeal air-pulse sensory stimulation can improve swallowing function and to explore associated changes in swallowing-related sensory-motor brain networks after stroke.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Zhiming Tang
- Numéro de téléphone: +86-0757-83161805
- E-mail: 104237506@qq.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Diagnosis of stroke according to the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases.
- Dysphagia confirmed by videofluoroscopic swallowing study (VFSS) or fiberoptic endoscopic evaluation of swallowing (FEES).
- Functional Oral Intake Scale (FOIS) score of 1-5.
- Stable vital signs.
- Time since stroke onset of at least 1 month.
- Age 18-76 years.
- No severe impairment of auditory comprehension and able to cooperate with study procedures.
- Written informed consent provided by the participant and/or family member, as applicable.
Exclusion Criteria:
- Other neurological or mental system disorders
- Severe sensory impairment.
- Severe cardiac, pulmonary, hepatic, or renal disease.
- History of seizures after stroke.
- Allergy in the relevant treatment area, or other contraindications to the study stimulation procedure.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Active Pharyngeal Air-Pulse Sensory Stimulation
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Active pharyngeal air-pulse sensory stimulation is delivered using a pharyngeal air-pulse sensory stimulation device.
The stimulation site is the anterior wall of the piriform sinus or the aryepiglottic fold.
Air-pulse stimulation is delivered at a frequency of 48 pulses per minute, with 1 minute of stimulation alternating with 1 minute of rest, for a total session duration of 20 minutes and approximately 480 air pulses per session.
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Comparateur factice: Sham Pharyngeal Air-Pulse Sensory Stimulation
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Sham pharyngeal air-pulse sensory stimulation is delivered using the same device.
The catheter insertion procedure, placement method, and duration are kept consistent with those used in the active stimulation group to maintain blinding.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Functional Oral Intake Scale (FOIS)
Délai: Baseline and immediately after completion of the 2-week intervention
|
The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale used to assess the functional level of oral food and liquid intake.
Scores range from 1 (nothing by mouth) to 7 (total oral diet with no restrictions).
Higher scores indicate better funct
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Baseline and immediately after completion of the 2-week intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Penetration-Aspiration Scale (PAS) Score
Délai: Baseline and immediately after completion of the 2-week intervention
|
The Penetration-Aspiration Scale (PAS) is an 8-point ordinal scale used to assess the severity of airway invasion during swallowing.
Scores range from 1 to 8, with a score of 1 indicating that material does not enter the airway and a score of 8 indicating that material passes below the vocal folds with no attempt to eject it.
Higher scores indicate greater severity of penetration or aspiration.
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Baseline and immediately after completion of the 2-week intervention
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Dysphagia Outcome and Severity Scale (DOSS) Score
Délai: Baseline and immediately after completion of the 2-week intervention
|
The Dysphagia Outcome and Severity Scale (DOSS) is a 7-point ordinal scale used to assess the functional severity of dysphagia and the level of dietary restriction and assistance required.
Scores range from 1 to 7, with a score of 1 indicating severe dysphagia with inability to safely tolerate oral intake and a score of 7 indicating normal swallowing with a regular diet and no need for compensatory strategies or additional time.
Higher scores indicate better swallowing function and lower severity of dysphagia.
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Baseline and immediately after completion of the 2-week intervention
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Oral Transit Time (OTT)
Délai: Baseline and immediately after completion of the 2-week intervention
|
Oral Transit Time (OTT) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in seconds (s).
OTT is defined as the time interval from the initiation of posterior oral bolus propulsion until the leading edge of the bolus reaches the ramus of the mandible.
Measurements will be obtained using predefined bolus consistencies and volumes.
|
Baseline and immediately after completion of the 2-week intervention
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Upper Esophageal Sphincter Opening (UO)
Délai: Baseline and immediately after completion of the 2-week intervention
|
Upper Esophageal Sphincter Opening (UO) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in millimeters (mm).
UO is defined as the maximum opening diameter of the upper esophageal sphincter during bolus passage, measured on the lateral VFSS image at the point of maximal opening.
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Baseline and immediately after completion of the 2-week intervention
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Hyoid Superior Movement (HSM)
Délai: Baseline and immediately after completion of the 2-week intervention
|
Hyoid Superior Movement (HSM) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in millimeters (mm).
HSM represents the maximum superior displacement of the hyoid bone from its resting position during swallowing.
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Baseline and immediately after completion of the 2-week intervention
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Hyoid Anterior Movement (HAM)
Délai: Baseline and immediately after completion of the 2-week intervention
|
Hyoid Anterior Movement (HAM) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in millimeters (mm).
HAM represents the maximum anterior displacement of the hyoid bone from its resting position during swallowing.
|
Baseline and immediately after completion of the 2-week intervention
|
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Laryngeal Closure Duration (LCD)
Délai: Baseline and immediately after completion of the 2-week intervention
|
Laryngeal Closure Duration (LCD) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in seconds (s).
LCD is defined as the time interval from complete closure of the laryngeal vestibule to subsequent reopening of the laryngeal vestibule during swallowing.
Measurements will be obtained using predefined bolus consistencies and volumes.
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Baseline and immediately after completion of the 2-week intervention
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Pharyngeal Transit Time (PTT)
Délai: Baseline and immediately after completion of the 2-week intervention
|
Pharyngeal Transit Time (PTT) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in seconds (s).
PTT is defined as the time interval from the leading edge of the bolus passing the ramus of the mandible until the trailing edge of the bolus passes through the upper esophageal sphincter.
A shorter PTT indicates faster pharyngeal bolus transport.
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Baseline and immediately after completion of the 2-week intervention
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Collaborateurs et enquêteurs
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Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Assoratgoon I, Shiraishi N, Tagaino R, Ogawa T, Sasaki K. Sensory neuromuscular electrical stimulation for dysphagia rehabilitation: A literature review. J Oral Rehabil. 2023 Feb;50(2):157-164. doi: 10.1111/joor.13391. Epub 2022 Nov 28.
- Clave P, Ortega O, Rofes L, Alvarez-Berdugo D, Tomsen N. Brain and Pharyngeal Responses Associated with Pharmacological Treatments for Oropharyngeal Dysphagia in Older Patients. Dysphagia. 2023 Dec;38(6):1449-1466. doi: 10.1007/s00455-023-10578-x. Epub 2023 May 5.
- Theurer JA, Johnston JL, Fisher J, Darling S, Stevens RC, Taves D, Teasell R, Hachinski V, Martin RE. Proof-of-principle pilot study of oropharyngeal air-pulse application in individuals with dysphagia after hemispheric stroke. Arch Phys Med Rehabil. 2013 Jun;94(6):1088-94. doi: 10.1016/j.apmr.2012.11.033. Epub 2012 Dec 5.
- Zhang M, Li C, Zhang F, Han X, Yang Q, Lin T, Zhou H, Tang M, Zhou J, Shi H, Hui Y, Xiong M, Pang L, Wang B, Feng Z, Li Z, Cao C, Lu X, Ding Y, Shen S, Xu Z, Yu F, Chen C, Meng L, Liao G, Zhang J, Sasegbon A, Dou Z. Prevalence of Dysphagia in China: An Epidemiological Survey of 5943 Participants. Dysphagia. 2021 Jun;36(3):339-350. doi: 10.1007/s00455-020-10138-7. Epub 2020 May 26.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 décembre 2029
Achèvement de l'étude (Estimé)
31 décembre 2029
Dates d'inscription aux études
Première soumission
19 août 2026
Première soumission répondant aux critères de contrôle qualité
20 août 2026
Première publication (Réel)
24 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FSYYY-EC-SOP-008-03.0-A08
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