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临床试验/NCT06350422
NCT06350422进行中(未招募)不适用

Neuroimage Genome Study of Neuroplasticity Associated With Microgravity

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
26
试验地点
1
主要终点
Brain structure - Morphology

研究概览

简要总结

This clinical trial investigates the neuroplasticity and cognitive status changes of the human brain in microgravity. To explore the relationship between cognitive status changes and brain functional activities, gray matter and white matter changes under microgravity exposure, screen and identify representative image markers, so as to provide decision-making information for the cognitive status changes of relevant personnel under microgravity environment.

详细描述

MRI has the advantage of non-invasive and non-radiation, and imaging the human brain after exposure to microgravity can reveal the neuroplastic changes in the astronaut's brain and discover the characteristics of functional activities behind it. The purpose of this study is to explore the image features and cognitive state related information related to the changes of human brain neuroplasticity under microgravity environment, and to identify the related image markers. At the same time, the pathophysiological mechanism is preliminarily discussed in this study. This study is helpful for us to explore the sensitivity of different brain structures and brain functions to space microgravity environment, so as to further understand the role and influence of space missions on brain health.

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 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male aged 18-60 years
  • No mental or other neurological disorders, no history of drug or alcohol abuse
  • Generally in good condition, no clear major physical diseases, no hearing disorders
  • No metal foreign bodies in the body, no contraindications to MRI scanning
  • No claustrophobia
  • Agree to participate in the clinical study and sign the informed consent

排除标准

  • There are electronic implants or metal foreign bodies, such as cardiac pacemakers
  • People with aneurysm surgery and intracranial aneurysm clip
  • People who have had heart surgery and used artificial heart valves
  • Having family planning
  • Uncontrolled epilepsy or mental illness, can't cooperate with MRI examination
  • Severe claustrophobia, can't cooperate with magnetic resonance examination
  • Other circumstances that the clinical trial personnel consider inappropriate to participate in the study

结局指标

主要结局

Brain structure - Morphology

时间窗: 60 days after the Head-Down tilt Bed Rest test

Based on 3D-T1WI, the changes of brain structure before and after the Head-Down tilt Bed Rest test were compared.

Local brain functional activity

时间窗: 60 days after the Head-Down tilt Bed Rest test

Based on resting-state functional MRI images, the changes of local brain functional activity before and after the Head-Down tilt Bed Rest test were compared.

Brain functional connectivity

时间窗: 60 days after the Head-Down tilt Bed Rest test

Based on resting-state functional MRI images, the changes of brain functional connectivity before and after the Head-Down tilt Bed Rest test were compared.

Brain fiber bundle and brain Diffusion index

时间窗: 60 days after the Head-Down tilt Bed Rest test

Based on diffusion tensor imaging, the changes of brain fiber bundle and brain diffusion index before and after the Head-Down tilt Bed Rest test were compared.

Brain blood flow

时间窗: 60 days after the Head-Down tilt Bed Rest test

Based on arterial spin labeling, the changes of brain blood flow before and after the Head-Down tilt Bed Rest test were compared.

Imaging indexes and clinical scale scores

时间窗: 60 days after the Head-Down tilt Bed Rest test

Based on the changes of relevant imaging indexes and the changes of relevant clinical scale scores, explore the correlation between the changes of relevant imaging indexes and relevant clinical scales scores.

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Lou

Director and Clinical Professor

Chinese PLA General Hospital

研究点 (1)

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