MicrogravityNCT06350422
Neuroimage Genome Study of Neuroplasticity Associated With Microgravity
An observational study of Microgravity and Neuroplasticity, run by Chinese PLA General Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Microgravity, Neuroplasticity, MRI
- What is being tested?
- Head-Down tilt Bed Rest test
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Volunteers who underwent 60 days of the Head-Down tilt Bed Rest test.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Microgravity, Neuroplasticity, MRI, Repeatable Battery for the Assessment of Neuropsychological Status
- Being tested
- Head-Down tilt Bed Rest test
- Keywords
- Microgravity, Neuroplasticity, MRI, Repeatable Battery for the Assessment of Neuropsychological Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-Down tilt Bed Rest testOther
All of the volunteers underwent 60 days of the Head-Down tilt Bed Rest test.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 days after the Head-Down tilt Bed Rest test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrogravityStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350422
- Sponsor's protocol ID
- Microgravity-ChinaPLAGH
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimage Genome Study of Neuroplasticity Associated With Microgravity
- ClinicalTrials.gov ID
- NCT06350422
- Acronym / sponsor ID
- Microgravity-ChinaPLAGH
- Conditions
- Microgravity, Neuroplasticity, MRI, Repeatable Battery for the Assessment of Neuropsychological Status
- Keywords
- Microgravity, Neuroplasticity, MRI, Repeatable Battery for the Assessment of Neuropsychological Status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers who underwent 60 days of the Head-Down tilt Bed Rest test.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-Down tilt Bed Rest testAll of the volunteers underwent 60 days of the Head-Down tilt Bed Rest test. | Other | – |
Primary outcome
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.
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.
Brain structure - Morphology
Time frame: 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.
Brain fiber bundle and brain Diffusion index
Time frame: 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
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.
Imaging indexes and clinical scale scores
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microgravity and Neuroplasticity, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local brain functional activity (time frame: 60 days after the Head-Down tilt Bed Rest test). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.