Neuroimage Genome Study of Neuroplasticity Associated With Microgravity

MRI Clinical Trial

Official title:

Neuroimage Genome Study of Neuroplasticity Associated With Microgravity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06350422
• Other study ID #: Microgravity-ChinaPLAGH
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• MRI
• Neuroplasticity

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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