跳至主要内容
临床试验/NCT06208020
NCT06208020招募中不适用

Cortical Activation and Functional Connectivity Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome

The First Affiliated Hospital of Zhengzhou University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
cortical activation during swallowing

研究概览

简要总结

The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). The main questions it aims to answer are:

  • The alteration of cortical activation during swallowing in patients with LMS compared with healthy subjects.
  • The alteration of cortical functional connectivity during swallowing in patients with LMS compared with healthy subjects.

fNIRS will be used to detect cortical activation and functional connectivity during swallowing tasks in LMS patients and healthy subjects, and to compare the differences between patients and healthy subjects.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The first ischemic stroke was confirmed by head MRI as LMS;
  • 18-80 years old, right-handed;
  • Dysphagia was confirmed by video fluoroscopic swallow study(VFSS);
  • Conscious enough to cooperate with fNIRS testing;
  • No previous neurological or mental illness.

排除标准

  • Other central nervous system diseases (Parkinson's disease, Alzheimer's disease, intracranial tumors, etc.);
  • Other diseases causing dysphagia (tumors of the esophagus, larynx, nasopharynx, etc.);
  • Serious physical diseases (cancer, fracture, etc.);
  • Other mental disorders (mania, schizophrenia, etc.);
  • Unconscious, unable to cooperate with the examination

结局指标

主要结局

cortical activation during swallowing

时间窗: day 1

The NirSpark package will be used to preprocess and analyze the fNIRS data. The steps will be used to preprocess the data including: deleting irrelevant time intervals and unrelated artifacts; turning the intensity of light into optical density; choosing the band-pass filter to filter the noise and interference signals (0.01-0.2 Hz); translating optical density to the oxygen concentration in the blood; and setting the initial time of the hemodynamic response function (HRF) to 30 s and the end time to 60 s (the time for a single block paradigm). To analyze the HbO2 time-series data, a generalized linear model (GLM) will be used. The GLM could calculate the degree of matching between the experimental and ideal HRF values for each task and participant. The beta value, which represents the channel's level of cortical activation, will be utilized to estimate the HRF prediction of the HbO2 signal and can be used to represent the HRF function's peak value.

次要结局

  • functional connectivity during swallowing(day 1)

研究者

发起方
The First Affiliated Hospital of Zhengzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Yi

Principal Investigator

The First Affiliated Hospital of Zhengzhou University

研究点 (1)

Loading locations...

相似试验