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

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.

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.