Mechanisms of Air-pulse Pharyngeal Sensory Stimulation Regulation Post-stroke Swallowing Neural Network Remodeling Via TRPV4 Channel
20 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
80
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Zhiming Tang
- Numero di telefono: +86-0757-83161805
- Email: 104237506@qq.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Functional Oral Intake Scale (FOIS)
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Penetration-Aspiration Scale (PAS) Score
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Oral Transit Time (OTT)
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Upper Esophageal Sphincter Opening (UO)
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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)
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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)
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Laryngeal Closure Duration (LCD)
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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)
Lasso di tempo: Baseline and immediately after completion of the 2-week intervention
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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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 agosto 2026
Completamento primario (Stimato)
31 dicembre 2029
Completamento dello studio (Stimato)
31 dicembre 2029
Date di iscrizione allo studio
Primo inviato
19 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
20 agosto 2026
Primo Inserito (Effettivo)
24 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FSYYY-EC-SOP-008-03.0-A08
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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