Clinical trial NCT06350422: Neuroimage Genome Study of Neuroplasticity Associated With Microgravity
Official title: Neuroimage Genome Study of Neuroplasticity Associated With Microgravity
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Microgravity
Neuroplasticity
MRI
Repeatable Battery for the Assessment of Neuropsychological Status
Keywords: Microgravity
Neuroplasticity
MRI
Repeatable Battery for the Assessment of Neuropsychological Status
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers who underwent 60 days of the Head-Down tilt Bed Rest test.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local brain functional activity
timeFrame: 60 days after the Head-Down tilt Bed Rest test
measure: Brain functional connectivity
timeFrame: 60 days after the Head-Down tilt Bed Rest test
measure: Brain structure - Morphology
timeFrame: 60 days after the Head-Down tilt Bed Rest test
measure: Brain fiber bundle and brain Diffusion index
timeFrame: 60 days after the Head-Down tilt Bed Rest test
measure: Brain blood flow
timeFrame: 60 days after the Head-Down tilt Bed Rest test
measure: Imaging indexes and clinical scale scores
timeFrame: 60 days after the Head-Down tilt Bed Rest test
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References: