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临床试验/NCT06703307
NCT06703307招募中不适用

Identifying Biomarkers Related to Post-stroke Cognitive Impairment: A fNIRS Study

Dingqun Bai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1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
60
试验地点
1
主要终点
Preliminary screening of brain function biomarkers for post-stroke cognitive impairment

研究概览

简要总结

This is an fNIRS study performed to identify biomarkers related to post-stroke cognitive impairment.

详细描述

This was an initial screening and preliminary intervention study. Both healthy subject and stroke patients will be included in this study. Brain functional activation of each subject during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS). Cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Biomarkers related to post-stroke cognitive impairment will be identified by by comparing differences in brain activation and brain network connectivity 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

  • Stroke patients:
  • Diagnosis of stroke confirmed by neuroimaging (CT or MRI)
  • 18-80 years old
  • Able to complete the cognitive task
  • Able to follow instructions to complete the trial
  • Patients who signed an informed consent form.
  • Healthy Subjects:
  • No abnormalities on cranial
  • 18-80 years old
  • Able to complete cognitive task
  • Able to follow instructions to complete the trial
  • not taking medications.
  • Subjects who signed an informed consent form.

排除标准

  • Stroke patients:
  • Inability to tolerate the test due to organic diseases
  • Serious mental illness that prevents them from cooperating with or tolerating the trial
  • Pregnant or lactating women
  • Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction.
  • Healthy Subjects:
  • Inability to tolerate the test due to organic diseases
  • Serious mental illness that prevents them from cooperating with or tolerating the trial.
  • Pregnant or lactating women
  • Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction

结局指标

主要结局

Preliminary screening of brain function biomarkers for post-stroke cognitive impairment

时间窗: 1 day

Comparison of differences in brain activation \[HbO2 (mmol/L\*mm)\] between patients with post-stroke cognitive impairment and patients without post-stroke cognitive impairment or healthy subjects

次要结局

未报告次要终点

研究者

发起方
Dingqun Bai
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dingqun Bai

Director of rehabilitation Medicine

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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