Neuroimage Genome Study of Neuroplasticity Associated With Microgravity

NCT06350422 | Active Not Recruiting

• 1 other identifier: Microgravity-ChinaPLAGH
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Local brain functional activity

  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.

  60 days after the Head-Down tilt Bed Rest test

• Brain functional connectivity

  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.

  60 days after the Head-Down tilt Bed Rest test

• Brain structure - Morphology

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

  60 days after the Head-Down tilt Bed Rest test

• Brain fiber bundle and brain Diffusion index

  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.

  60 days after the Head-Down tilt Bed Rest test

• Brain blood flow

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

  60 days after the Head-Down tilt Bed Rest test

• Imaging indexes and clinical scale scores

  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.

  60 days after the Head-Down tilt Bed Rest test

Interventions

Head-Down tilt Bed Rest test OTHER

All of the volunteers underwent 60 days of the Head-Down tilt Bed Rest test.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers who underwent 60 days of the Head-Down tilt Bed Rest test.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Clinical Professor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: January 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

CN (1)