Clinical Trials in Germany / NCT04856410
Enrolling by invitation
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Effects of Long-Duration Spaceflight on General and Spatial Cognition and Its Neural Basis
NCT04856410 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Brain StructureCognitive Performance
Investigational drug(s) / intervention(s)
SpaceflightControls
Spaceflight: Exposure to the spaceflight environment on the International Space Station for 2, 6, or 12 months.
Controls: No intervention
Study summary
This study investigates the effects of extended-duration spaceflight (12-month International Space Station missions) on general cognitive performance (measured with the Cognition test battery), spatial cognition, structural and functional brain changes in general, and hippocampal plasticity more specifically relative to the shorter 6-month and 2-month missions.
Eligibility
Inclusion Criteria:
1. Astronauts (according to NASA requirements)
2. Normal, healthy volunteers (astronaut surrogates) - Astronaut surrogates will be matched for sex, age and education relative to astronauts
Exclusion Criteria:
For astronauts and normal, healthy volunteers (astronaut surrogates):
1. Subjects that do not comply with the MRI testing requirements. The following and other conditions may exclude the subject from MRI scanning or require additional examination to assess specific contraindications:
* Tinnitus;
* Sensori-neural hearing loss \> 30 decibels (dB);
* Pace-maker or internal defibrillator;
* metallic implants (e.g. orthopedic plates after bone fractures, joint replacements, surgical staples or clips, artificial heart valves, stents, cava filters);
* Metallic splinters (e.g. after an accident or due to war injury);
* Non-removable dental brace;
* Intrauterine contraceptive devices (IUD) that are not MRI-compatible;
* Cochlear implant (implanted hearing device);
* Medication pump;
* Acupuncture needle;
* Other foreign bodies/objects which are non-removable;
* Pregnancy (or its possibility);
* Previous brain and/or heart surgery.
* Tattoos and/or permanent make-up in the body (some inks contain metallic particles).
2. Female subjects in this study are either astronauts or will model those in the astronaut population for whom participation in space missions is not allowed during pregnancy.
Primary outcome measure(s)
- Cognitive performance — Change from pre-flight performance (average of tests performed 180, 120 and 60 days prior to launch) to in-flight performance (average of all tests: 1 month mission = 1 test, 2 months = 2 tests, 6 months = 6 tests, 12 months = 12 tests)
Cognitive efficiency across domains as determined with the Cognition test battery - Local task activation Cognition — Change from pre-flight local task activation (investigated 60 days prior to launch) to post-flight local task activation (investigated 5 days and 30 days after return to Earth)
fMRI local task activation while performing the MRI version of Cognition in the scanner - Spatial cognition performance — Change from pre-flight performance (average of tests performed 180, 120 and 60 days prior to launch) to in-flight performance (average of all tests: 1 month mission = 1 test, 2 months = 2 tests, 6 months = 4 tests, 12 months = 7 tests)
Accuracy and reaction times for each cognitive task as determined with the Spatial Cognition test batteries - Structural brain changes — Change from pre-flight local task activation (investigated 60 days prior to launch) to post-flight (investigated 5 days and 30 days after return to Earth)
Structural brain changes assessed with MRI - Local task activation Spatial Cognition — Change from pre-flight local task activation (investigated 60 days prior to launch) to post-flight local task activation (investigated 5 days and 30 days after return to Earth)
fMRI local task activation while performing visuospatial tasks in the scanner - Brain-Derived Neurotropic Factor (BDNF) — Change from pre-flight values (average of blood drawn180 and 60 days prior to launch) to in-flight values (average of all in-flight blood draws: 1 month mission = 1 draw, 2 months = 2 draws, 6 months = 4 draws,12 months = 7 draws)
Changes in Brain-Derived Neurotropic Factor (BDNF)
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | |
| Johnson Space Center (JSC) | Houston | Texas | |
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04856410 on ClinicalTrials.gov ↗ ← All trials in Germany