Neuroimage Genome Study of Neuroplasticity Associated With Microgravity

Active, not recruiting

• Conditions: MRI; Microgravity; Neuroplasticity; Repeatable Battery for the Assessment of Neuropsychological Status

• Registration Number: NCT06350422
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain structure - Morphology	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	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	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	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	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	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.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China