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Brain StructureNCT04856410

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

A study testing Spaceflight in people with Brain Structure and Cognitive Performance, run by University of Pennsylvania at 3 sites in 2 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Brain Structure, Cognitive Performance
What is being tested?
Spaceflight
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesin 2 countries
Study dates
1 Aug 2021to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Astronauts (according to NASA requirements)
  • Normal, healthy volunteers (astronaut surrogates) - Astronaut surrogates will be matched for sex, age and education relative to astronauts

Who cannot join

  • For astronauts and normal, healthy volunteers (astronaut surrogates):
  • 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);
Show all 17Show fewer
  • 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).
  • 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 locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

3 sites in 2 countries

United States2 sites

  • Johnson Space Center (JSC)

    Houston, Texas, 77058

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Germany1 site

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

Other trials in Germany

About this study

Official title: Temporal Nature of Cognitive and Visuospatial Brain Domain Changes During Long-Duration Low-Earth Orbit Missions (Spatial Cognition)

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.

Read the 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.

Being tested
Spaceflight, Controls
Keywords
Astronauts, Spaceflight, Cognition, Long Duration Spaceflight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpaceflightOther

    Exposure to the spaceflight environment on the International Space Station for 2, 6, or 12 months.

  • ControlsOther

    No intervention

Study groups in NCT04856410
Study groupRoleWhat they receive
6-Month ArmExperimentalAstronauts 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.
Receives: Other: Spaceflight
12-Month ArmExperimentalAstronauts 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.
Receives: Other: Spaceflight
No InterventionExperimentalSubjects matched to 12-month astronauts that stay on Earth and are investigated at similar time points.
Receives: Other: Controls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive performance

    Cognitive efficiency across domains as determined with the Cognition test battery

    Measured: 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)

  2. Local task activation Cognition

    fMRI local task activation while performing the MRI version of Cognition in the scanner

    Measured: 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)

  3. Spatial cognition performance

    Accuracy and reaction times for each cognitive task as determined with the Spatial Cognition test batteries

    Measured: 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)

  4. Structural brain changes

    Structural brain changes assessed with MRI

    Measured: 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)

  5. Local task activation Spatial Cognition

    fMRI local task activation while performing visuospatial tasks in the scanner

    Measured: 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)

  6. Brain-Derived Neurotropic Factor (BDNF)

    Changes in Brain-Derived Neurotropic Factor (BDNF)

    Measured: 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 outcomes (7)

  1. Insulin-like Growth Factor 1 (IGF-1)

    Changes in Insulin-like Growth Factor 1 (IGF-1)

    Measured: 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)

  2. Vascular Endothelial Growth Factor (VEGF)

    Changes in Vascular Endothelial Growth Factor (VEGF)

    Measured: 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)

  3. Oxytocin

    Changes in Oxytocin

    Measured: 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)

  4. Interleukin (IL)-1

    Changes in Interleukin (IL)-1

    Measured: 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)

  5. Interleukin (IL)-1ra

    Changes in Interleukin (IL)-1ra

    Measured: 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)

  6. Interleukin (IL)-10

    Changes in Interleukin (IL)-10

    Measured: 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)

  7. Tumor Necrosis Factor a (TNFa)

    Changes in Tumor Necrosis Factor a (TNFa)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start1 Aug 2021
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study will investigate 5 astronauts on 6-month ISS missions, 2 astronauts on 12-month ISS missions, and 7 control subjects that are matched to astronauts and investigated at similar time points.
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856410
Sponsor's protocol ID
843851
Other IDs
80NSSC19K1046, 50WB2115
Status last verified
Oct 2026
First submitted
25 Feb 2021
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There will only be data sharing within our research group (CIPHER).

Publications

  • Basner M, Moore TM, Hermosillo E, Nasrini J, Dinges DF, Gur RC, Johannes B. Cognition Test Battery Performance Is Associated with Simulated 6df Spacecraft Docking Performance. Aerosp Med Hum Perform. 2020 Nov 1;91(11):861-867. doi: 10.3357/AMHP.5602.2020.

    PubMed 33334406

  • Afshinnekoo E, Scott RT, MacKay MJ, Pariset E, Cekanaviciute E, Barker R, Gilroy S, Hassane D, Smith SM, Zwart SR, Nelman-Gonzalez M, Crucian BE, Ponomarev SA, Orlov OI, Shiba D, Muratani M, Yamamoto M, Richards SE, Vaishampayan PA, Meydan C, Foox J, Myrrhe J, Istasse E, Singh N, Venkateswaran K, Keune JA, Ray HE, Basner M, Miller J, Vitaterna MH, Taylor DM, Wallace D, Rubins K, Bailey SM, Grabham P, Costes SV, Mason CE, Beheshti A. Fundamental Biological Features of Spaceflight: Advancing the Field to Enable Deep-Space Exploration. Cell. 2020 Nov 25;183(5):1162-1184. doi: 10.1016/j.cell.2020.10.050.

    PubMed 33242416

  • Basner M, Hermosillo E, Nasrini J, Saxena S, Dinges DF, Moore TM, Gur RC. Cognition test battery: Adjusting for practice and stimulus set effects for varying administration intervals in high performing individuals. J Clin Exp Neuropsychol. 2020 Jul;42(5):516-529. doi: 10.1080/13803395.2020.1773765. Epub 2020 Jun 15.

    PubMed 32539487

  • Nasrini J, Hermosillo E, Dinges DF, Moore TM, Gur RC, Basner M. Cognitive Performance During Confinement and Sleep Restriction in NASA's Human Exploration Research Analog (HERA). Front Physiol. 2020 Apr 28;11:394. doi: 10.3389/fphys.2020.00394. eCollection 2020.

    PubMed 32411017

  • Lee G, Moore TM, Basner M, Nasrini J, Roalf DR, Ruparel K, Port AM, Dinges DF, Gur RC. Age, Sex, and Repeated Measures Effects on NASA's "Cognition" Test Battery in STEM Educated Adults. Aerosp Med Hum Perform. 2020 Jan 1;91(1):18-25. doi: 10.3357/AMHP.5485.2020.

    PubMed 31852569

  • Scully RR, Basner M, Nasrini J, Lam CW, Hermosillo E, Gur RC, Moore T, Alexander DJ, Satish U, Ryder VE. Effects of acute exposures to carbon dioxide on decision making and cognition in astronaut-like subjects. NPJ Microgravity. 2019 Jun 19;5:17. doi: 10.1038/s41526-019-0071-6. eCollection 2019.

    PubMed 31240239

  • Garrett-Bakelman FE, Darshi M, Green SJ, Gur RC, Lin L, Macias BR, McKenna MJ, Meydan C, Mishra T, Nasrini J, Piening BD, Rizzardi LF, Sharma K, Siamwala JH, Taylor L, Vitaterna MH, Afkarian M, Afshinnekoo E, Ahadi S, Ambati A, Arya M, Bezdan D, Callahan CM, Chen S, Choi AMK, Chlipala GE, Contrepois K, Covington M, Crucian BE, De Vivo I, Dinges DF, Ebert DJ, Feinberg JI, Gandara JA, George KA, Goutsias J, Grills GS, Hargens AR, Heer M, Hillary RP, Hoofnagle AN, Hook VYH, Jenkinson G, Jiang P, Keshavarzian A, Laurie SS, Lee-McMullen B, Lumpkins SB, MacKay M, Maienschein-Cline MG, Melnick AM, Moore TM, Nakahira K, Patel HH, Pietrzyk R, Rao V, Saito R, Salins DN, Schilling JM, Sears DD, Sheridan CK, Stenger MB, Tryggvadottir R, Urban AE, Vaisar T, Van Espen B, Zhang J, Ziegler MG, Zwart SR, Charles JB, Kundrot CE, Scott GBI, Bailey SM, Basner M, Feinberg AP, Lee SMC, Mason CE, Mignot E, Rana BK, Smith SM, Snyder MP, Turek FW. The NASA Twins Study: A multidimensional analysis of a year-long human spaceflight. Science. 2019 Apr 12;364(6436):eaau8650. doi: 10.1126/science.aau8650.

    PubMed 30975860

  • 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.

    PubMed 29357516

  • Moore TM, Basner M, Nasrini J, Hermosillo E, Kabadi S, Roalf DR, McGuire S, Ecker AJ, Ruparel K, Port AM, Jackson CT, Dinges DF, Gur RC. Validation of the Cognition Test Battery for Spaceflight in a Sample of Highly Educated Adults. Aerosp Med Hum Perform. 2017 Oct 1;88(10):937-946. doi: 10.3357/AMHP.4801.2017.

    PubMed 28923143

  • 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.

    PubMed 26564759

  • Basner M, Dinges DF, Mollicone DJ, Savelev I, Ecker AJ, Di Antonio A, Jones CW, Hyder EC, Kan K, Morukov BV, Sutton JP. Psychological and behavioral changes during confinement in a 520-day simulated interplanetary mission to mars. PLoS One. 2014 Mar 27;9(3):e93298. doi: 10.1371/journal.pone.0093298. eCollection 2014.

    PubMed 24675720

  • Basner M, Dinges DF, Mollicone D, Ecker A, Jones CW, Hyder EC, Di Antonio A, Savelev I, Kan K, Goel N, Morukov BV, Sutton JP. Mars 520-d mission simulation reveals protracted crew hypokinesis and alterations of sleep duration and timing. Proc Natl Acad Sci U S A. 2013 Feb 12;110(7):2635-40. doi: 10.1073/pnas.1212646110. Epub 2013 Jan 7.

    PubMed 23297197

  • Mendt S, Gunga HC, Felsenberg D, Belavy DL, Steinach M, Stahn AC. Regular exercise counteracts circadian shifts in core body temperature during long-duration bed rest. NPJ Microgravity. 2021 Jan 5;7(1):1. doi: 10.1038/s41526-020-00129-1.

    PubMed 33402671

  • Chouker A, Stahn AC. COVID-19-The largest isolation study in history: the value of shared learnings from spaceflight analogs. NPJ Microgravity. 2020 Oct 22;6:32. doi: 10.1038/s41526-020-00122-8. eCollection 2020.

    PubMed 33110938

  • Friedl-Werner A, Brauns K, Gunga HC, Kuhn S, Stahn AC. Exercise-induced changes in brain activity during memory encoding and retrieval after long-term bed rest. Neuroimage. 2020 Dec;223:117359. doi: 10.1016/j.neuroimage.2020.117359. Epub 2020 Sep 10.

    PubMed 32919056

Questions about this trial

What is this clinical trial studying?

A study testing Spaceflight in people with Brain Structure and Cognitive Performance, run by University of Pennsylvania at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive performance (time frame: 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04856410, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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