Effects of Long-Duration Spaceflight on General and Spatial Cognition and Its Neural Basis

Not Applicable

• Conditions: Brain Structure; Cognitive Performance
• Interventions: Other: Spaceflight; Other: Controls

• Registration Number: NCT04856410
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

This is an international proposal consisting of two projects with synergistic aims that will be carried out in a joint effort by the National Aeronautics and Space Administration (NASA) and the German Aerospace Center (DLR) as well as the European Space Agency (ESA). The project targets NASA's particular interest in studying the 'Cognitive-perceptual-visuospatial brain domain changes due to isolation and confinement' as part of the Complement of Integrated Protocols for Human Exploration Research (CIPHER) project on the International Space Station (ISS). The collected data will demonstrate whether prolonging mission duration to one year will have detrimental effects 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 ISS missions. Using state-of-the-art neuroimaging techniques, investigators will determine the biological basis for any changes in cognitive performance, with a focus on hippocampal plasticity and spatial cognition. Similar data already gathered on the ISS and in several short- and long-duration space analog environments will be used to generate a normative data base for long-duration missions. Finally, investigators will derive dose-response relationships between cognitive-visuospatial brain domain changes and mission duration that will allow predicting vulnerability to adverse cognitive or behavioral impairment and psychiatric disorders on interplanetary expeditions such as a mission to Mars. The two projects will deliver a highly unique and comprehensive set of integrated neuroimaging and neurocognitive tools for the evaluation and ultimately prevention of adverse effects on brain structure and function that lead to behavioral effects associated with exploration-type missions.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-23
• Study Start: 2021-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Primary Completion: 2033-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-Month Arm	Spaceflight	Astronauts on 12-month International Space Station missions will be exposed to spaceflight for a duration of 12 months. Biometric and cognitive data will routinely be collected.
No Intervention	Controls	Subjects matched to 12-month astronauts that stay on Earth and are investigated at similar time points.
2-Month Arm	Spaceflight	Astronauts on 2-month International Space Station missions will be exposed to spaceflight for a duration of 2 months. Biometric and cognitive data will routinely be collected.
6-Month Arm	Spaceflight	Astronauts on 6-month International Space Station missions will be exposed to spaceflight for a duration of 6 months. Biometric and cognitive data will routinely be collected.

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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)	Changes in Interleukin (IL)-1
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)	Changes in Oxytocin
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)	Changes in Interleukin (IL)-1ra
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)	Changes in Insulin-like Growth Factor 1 (IGF-1)
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)	Changes in Vascular Endothelial Growth Factor (VEGF)
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)	Changes in Tumor Necrosis Factor a (TNFa)
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)	Changes in Interleukin (IL)-10

Trial Locations

Locations (3)

University of Pennsylvania Perelman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Johnson Space Center (JSC); 🇺🇸 Houston, Texas, United States