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

NCT07782424 | Not Yet Recruiting

• 1 other identifier: FSYYY-EC-SOP-008-03.0-A08
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Dysphagia

Outcome Measures

Primary Outcomes (1)

• The Functional Oral Intake Scale (FOIS)

  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

Secondary Outcomes (2)

• Penetration-Aspiration Scale (PAS) Score

  Baseline and immediately after completion of the 2-week intervention

• Dysphagia Outcome and Severity Scale (DOSS) Score

  Baseline and immediately after completion of the 2-week intervention

Other Outcomes (6)

• Oral Transit Time (OTT)

  Baseline and immediately after completion of the 2-week intervention

• Upper Esophageal Sphincter Opening (UO)

  Baseline and immediately after completion of the 2-week intervention

• Hyoid Superior Movement (HSM)

  Baseline and immediately after completion of the 2-week intervention

Study Arms (2)

Active Pharyngeal Air-Pulse Sensory Stimulation

EXPERIMENTAL

Device: Air-Pulse Sensory Stimulation

Sham Pharyngeal Air-Pulse Sensory Stimulation

SHAM COMPARATOR

Device: sham intervention

Interventions

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.

Active Pharyngeal Air-Pulse Sensory Stimulation

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.

Sham Pharyngeal Air-Pulse Sensory Stimulation

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Foshan: lead

Related Publications (4)

• 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.

  PMID: 37145201 BACKGROUND

• 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.

  PMID: 23219777 BACKGROUND

• 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.

  PMID: 36357332 BACKGROUND

• 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.

  PMID: 32458145 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Zhiming Tang

CONTACT

+86-0757-83161805; 104237506@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share