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Enrolling By Invitation
NCT04856410
Effects of Long-Duration Spaceflight on General and Spatial Cognition and Its Neural Basis
Conditions: Brain Structure, Cognitive Performance
Sex: All
Healthy volunteers: Yes
Phase: NA
Enrollment: 14
Sponsor: University of Pennsylvania
Location: University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania
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 Criteria
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.
Source: ClinicalTrials.gov (NCT04856410). StuddyBuddy aggregates publicly available trial information.