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

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University of Pennsylvania

Status

Invitation-only

Conditions

Brain Structure
Cognitive Performance

Treatments

Other: Controls
Other: Spaceflight

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04856410
843851
80NSSC19K1046 (Other Grant/Funding Number)
50WB2115 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

14 participants in 3 patient groups

6-Month Arm
Experimental group
Description:
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.
Treatment:
Other: Spaceflight
12-Month Arm
Experimental group
Description:
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.
Treatment:
Other: Spaceflight
No Intervention
Experimental group
Description:
Subjects matched to 12-month astronauts that stay on Earth and are investigated at similar time points.
Treatment:
Other: Controls

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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