跳至主要内容
临床试验/NCT05376098
NCT05376098Unknown不适用

A Temporal Study of Brain Motor Regions of Acute Ischemic Stroke Based on fNIRS

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
fNIRS characteristics of upper limb movement

研究概览

简要总结

The investigators evaluate the activation and connectivity of patients' motor regions in the acute phase of ischemic stroke by fNIRS.

详细描述

This study aims to analyze the progress of brain recovery from upper-limb deficit due to acute ischemic stroke, using Functional Near-infrared Spectroscopy(fNIRS) as the main neural imaging method. Fifty patients having experienced a stroke onset within seven days will be recruited from the emergency room. The fNIRS signals will be recorded bilaterally over the contralateral sensorimotor cortex, the premotor area, the supplementary motor area, the primary motor cortex for 14 days after being diagnosed. Then compute activation and connectivity of the regions. The motor function data measured by the assessment scales, as well as the behavioral record during the fNIRS motor tasks will be collected as well.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The diagnosis of ischemic stroke should meet the diagnostic criteria of the "China Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018".
  • 18 years old≤ age ≤ 75 years old.
  • Cerebral ischemic stroke onset within 7 days.
  • First onset.
  • Upper limb motor dysfunction.

排除标准

  • Unstable vital signs.
  • Complicated with other diseases in the nervous system.
  • Combined with other serious disease states: circulatory system, respiratory system,
  • motor system diseases, such as atrial fibrillation, heart failure, lung infection, severe liver and kidney dysfunction, lower limb venous thrombosis, etc.
  • Upper limb dysfunction caused by other reasons, such as fractures, upper limb deformities, etc.
  • Contraindicated to imaging tests, such as metal implantation, claustrophobia, and severe obesity.
  • Those who cannot complete the examination due to other reasons, such as mental disorders, cognitive dysfunction, etc.
  • Other causes: alcoholism; pregnancy; skull defects; soft tissue injuries at the site of examination; visual impairment, etc.

结局指标

主要结局

fNIRS characteristics of upper limb movement

时间窗: 0-14 day

The changes in brain oxygen levels are collected in two wavelengths, including 845 and 763 nanometers using a 44 channeled fNIRS machine. The data is used to determine the position of the activated area of the brain and functional connectivity during the movement. The locations of fNIRS channels on the skull of individuals are determined due to the observations on the cortical regions of interest (ROIs), namely the contralateral sensorimotor cortex (SMC), the contralateral premotor cortex (PMC) and primary motor cortex (M1), etc.

Assessment of upper limb function

时间窗: 0-14 day

Evaluating the motor function by Fugl-meyer assessment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

An fNIRS Study of Motor Cortical Activation in Stoke... | 临床试验