Mechanisms of Air-pulse Pharyngeal Sensory Stimulation Regulation Post-stroke Swallowing Neural Network Remodeling Via TRPV4 Channel
2026년 8월 20일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Zhiming Tang
- 전화번호: +86-0757-83161805
- 이메일: 104237506@qq.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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- 고령자
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예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Active Pharyngeal Air-Pulse Sensory Stimulation
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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.
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가짜 비교기: Sham Pharyngeal Air-Pulse Sensory Stimulation
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Functional Oral Intake Scale (FOIS)
기간: Baseline and immediately after completion of the 2-week intervention
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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
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Baseline and immediately after completion of the 2-week intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Penetration-Aspiration Scale (PAS) Score
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Dysphagia Outcome and Severity Scale (DOSS) Score
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oral Transit Time (OTT)
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Upper Esophageal Sphincter Opening (UO)
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Hyoid Superior Movement (HSM)
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Hyoid Anterior Movement (HAM)
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Laryngeal Closure Duration (LCD)
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Pharyngeal Transit Time (PTT)
기간: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2029년 12월 31일
연구 완료 (추정된)
2029년 12월 31일
연구 등록 날짜
최초 제출
2026년 8월 19일
QC 기준을 충족하는 최초 제출
2026년 8월 20일
처음 게시됨 (실제)
2026년 8월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 20일
마지막으로 확인됨
2026년 8월 1일
추가 정보
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