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

NCT07782424 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • First People's Hospital of Foshan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-12-31
Completion
2029-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782424 on ClinicalTrials.gov