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Mechanisms of Air-pulse Pharyngeal Sensory Stimulation Regulation Post-stroke Swallowing Neural Network Remodeling Via TRPV4 Channel

20 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  1. Diagnosis of stroke according to the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases.
  2. Dysphagia confirmed by videofluoroscopic swallowing study (VFSS) or fiberoptic endoscopic evaluation of swallowing (FEES).
  3. Functional Oral Intake Scale (FOIS) score of 1-5.
  4. Stable vital signs.
  5. Time since stroke onset of at least 1 month.
  6. Age 18-76 years.
  7. No severe impairment of auditory comprehension and able to cooperate with study procedures.
  8. Written informed consent provided by the participant and/or family member, as applicable.

Exclusion Criteria:

  1. Other neurological or mental system disorders
  2. Severe sensory impairment.
  3. Severe cardiac, pulmonary, hepatic, or renal disease.
  4. History of seizures after stroke.
  5. Allergy in the relevant treatment area, or other contraindications to the study stimulation procedure.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active Pharyngeal Air-Pulse Sensory Stimulation
Apparaat: Air-Pulse Sensory Stimulation
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.
Sham-vergelijker: Sham Pharyngeal Air-Pulse Sensory Stimulation
Apparaat: sham intervention
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Functional Oral Intake Scale (FOIS)
Tijdsspanne: 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
Baseline and immediately after completion of the 2-week intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Penetration-Aspiration Scale (PAS) Score
Tijdsspanne: 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.
Baseline and immediately after completion of the 2-week intervention
Dysphagia Outcome and Severity Scale (DOSS) Score
Tijdsspanne: 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.
Baseline and immediately after completion of the 2-week intervention

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Oral Transit Time (OTT)
Tijdsspanne: 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
Upper Esophageal Sphincter Opening (UO)
Tijdsspanne: 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.
Baseline and immediately after completion of the 2-week intervention
Hyoid Superior Movement (HSM)
Tijdsspanne: 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.
Baseline and immediately after completion of the 2-week intervention
Hyoid Anterior Movement (HAM)
Tijdsspanne: 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
Laryngeal Closure Duration (LCD)
Tijdsspanne: 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.
Baseline and immediately after completion of the 2-week intervention
Pharyngeal Transit Time (PTT)
Tijdsspanne: 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.
Baseline and immediately after completion of the 2-week intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

First People's Hospital of Foshan

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

19 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FSYYY-EC-SOP-008-03.0-A08

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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