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NCT Number: NCT07782424

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

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.

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Air-Pulse Sensory Stimulation

Device

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 intervention

Device

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.

Primary outcomes

  1. The Functional Oral Intake Scale (FOIS)

    Time frame: 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

Secondary outcomes

  1. Penetration-Aspiration Scale (PAS) Score

    Time frame: 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.

  2. Dysphagia Outcome and Severity Scale (DOSS) Score

    Time frame: 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.

Other outcomes

  1. Oral Transit Time (OTT)

    Time frame: 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.

  2. Upper Esophageal Sphincter Opening (UO)

    Time frame: 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.

  3. Hyoid Superior Movement (HSM)

    Time frame: 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.

  4. Hyoid Anterior Movement (HAM)

    Time frame: 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.

  5. Laryngeal Closure Duration (LCD)

    Time frame: 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.

  6. Pharyngeal Transit Time (PTT)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiming Tang

CONTACT

[email protected]

+86-0757-83161805

Sponsors and collaborators

Lead sponsor

First People's Hospital of Foshan

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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