- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06350422
Neuroimage Genome Study of Neuroplasticity Associated With Microgravity
April 1, 2024 updated by: Xin Lou, Chinese PLA General Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Chinese PLA General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Volunteers who underwent 60 days of the Head-Down tilt Bed Rest test.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local brain functional activity
Time Frame: 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.
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60 days after the Head-Down tilt Bed Rest test
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Brain functional connectivity
Time Frame: 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.
|
60 days after the Head-Down tilt Bed Rest test
|
Brain structure - Morphology
Time Frame: 60 days after the Head-Down tilt Bed Rest test
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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
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Brain fiber bundle and brain Diffusion index
Time Frame: 60 days after the Head-Down tilt Bed Rest test
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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.
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60 days after the Head-Down tilt Bed Rest test
|
Brain blood flow
Time Frame: 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.
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60 days after the Head-Down tilt Bed Rest test
|
Imaging indexes and clinical scale scores
Time Frame: 60 days after the Head-Down tilt Bed Rest test
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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.
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60 days after the Head-Down tilt Bed Rest test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
October 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
April 1, 2024
First Submitted That Met QC Criteria
April 1, 2024
First Posted (Actual)
April 5, 2024
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Microgravity-ChinaPLAGH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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