Mechanisms of Air-pulse Pharyngeal Sensory Stimulation Regulation Post-stroke Swallowing Neural Network Remodeling Via TRPV4 Channel
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- The Functional Oral Intake Scale (FOIS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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-
- •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.
排除标准
- •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.
结局指标
主要结局
The Functional Oral Intake Scale (FOIS)
时间窗: 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
次要结局
- 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)
研究者
Zhiming Tang
Associate chief physician
First People's Hospital of Foshan