Cognitive Performance Clinical Trial
Official title:
Temporal Nature of Cognitive and Visuospatial Brain Domain Changes During Long-Duration Low-Earth Orbit Missions (Spatial Cognition)
Verified date | October 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | December 31, 2033 |
Est. primary completion date | December 31, 2033 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
United States | Johnson Space Center (JSC) | Houston | Texas |
United States | University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Charite University, Berlin, Germany, DLR German Aerospace Center, National Aeronautics and Space Administration (NASA) |
United States, Germany,
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Basner M, Nasrini J, Hermosillo E, McGuire S, Dinges DF, Moore TM, Gur RC, Rittweger J, Mulder E, Wittkowski M, Donoviel D, Stevens B, Bershad EM; SPACECOT Investigator Group. Effects of -12 degrees head-down tilt with and without elevated levels of CO2 on cognitive performance: the SPACECOT study. J Appl Physiol (1985). 2018 Mar 1;124(3):750-760. doi: 10.1152/japplphysiol.00855.2017. Epub 2017 Dec 14. — View Citation
Basner M, Savitt A, Moore TM, Port AM, McGuire S, Ecker AJ, Nasrini J, Mollicone DJ, Mott CM, McCann T, Dinges DF, Gur RC. Development and Validation of the Cognition Test Battery for Spaceflight. Aerosp Med Hum Perform. 2015 Nov;86(11):942-52. doi: 10.3357/AMHP.4343.2015. — View Citation
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive performance | Cognitive efficiency across domains as determined with the Cognition test battery | 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) | |
Primary | Local task activation Cognition | fMRI local task activation while performing the MRI version of Cognition in the scanner | 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) | |
Primary | Spatial cognition performance | Accuracy and reaction times for each cognitive task as determined with the Spatial Cognition test batteries | 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) | |
Primary | Structural brain changes | Structural brain changes assessed with MRI | 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) | |
Primary | Local task activation Spatial Cognition | fMRI local task activation while performing visuospatial tasks in the scanner | 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) | |
Primary | Brain-Derived Neurotropic Factor (BDNF) | Changes in 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) | |
Secondary | Insulin-like Growth Factor 1 (IGF-1) | Changes in Insulin-like Growth Factor 1 (IGF-1) | 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) | |
Secondary | Vascular Endothelial Growth Factor (VEGF) | Changes in Vascular Endothelial Growth Factor (VEGF) | 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) | |
Secondary | Oxytocin | Changes in Oxytocin | 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) | |
Secondary | Interleukin (IL)-1 | Changes in Interleukin (IL)-1 | 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) | |
Secondary | Interleukin (IL)-1ra | Changes in Interleukin (IL)-1ra | 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) | |
Secondary | Interleukin (IL)-10 | Changes in Interleukin (IL)-10 | 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) | |
Secondary | Tumor Necrosis Factor a (TNFa) | Changes in Tumor Necrosis Factor a (TNFa) | 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) |
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