Spaceflight Effects on Cognitive Functioning

Recruiting at 2 trial locations

Overseen By Alexander Stahn, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Tinnitus, Hearing loss, Metallic implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a medication pump, it may affect your eligibility for MRI testing.

What data supports the effectiveness of the treatment Spaceflight on cognitive functioning?

The research suggests that spaceflight can lead to changes in cognitive performance, with some studies indicating impairments in tasks like visuospatial performance and dual-task performance. However, these effects may be influenced by stressors rather than spaceflight itself, and improvements in task design and astronaut training could mitigate these issues. ^{1 2 3 4 5}

Is spaceflight generally safe for cognitive functioning in humans?

Spaceflight can affect cognitive performance, with some individuals experiencing changes in attention, memory, and other cognitive functions. However, the evidence is not strong enough to confirm specific cognitive deficits, and effects can vary widely among individuals. ^{1 6 7 8 9}

How does the spaceflight treatment affect cognitive functioning compared to other treatments?

The spaceflight treatment is unique because it examines the effects of being in a microgravity environment on cognitive functioning, which is not addressed by standard treatments on Earth. This treatment is novel as it explores how the stress and conditions of space travel might alter brain performance, unlike traditional therapies that do not consider these extreme environmental factors. ^{1 3 8 10 11}

Eligibility Criteria

This trial is for astronauts who meet NASA's criteria and healthy volunteers matched in age and education to the astronauts. Participants must be able to undergo MRI scans, not have significant hearing loss, implanted medical devices, previous major brain or heart surgery, pregnancy potential, tattoos with metallic ink, or non-removable metal objects in their body.

Inclusion Criteria

Astronauts (according to NASA requirements)

I am healthy and my age and education match those of astronauts.

Exclusion Criteria

You have metal fragments in your body from an accident or injury, such as shrapnel from a bomb or a metal object that got stuck in your body.

You have received acupuncture treatment with needles.

I have had surgery on my brain or heart.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-flight Baseline

Participants undergo baseline cognitive and biometric assessments prior to spaceflight

6 months

Multiple visits for assessments

Spaceflight (2-Month Arm)

Astronauts on 2-month missions undergo cognitive and biometric assessments during spaceflight

2 months

2 in-flight assessments

Spaceflight (6-Month Arm)

Astronauts on 6-month missions undergo cognitive and biometric assessments during spaceflight

6 months

6 in-flight assessments

Spaceflight (12-Month Arm)

Astronauts on 12-month missions undergo cognitive and biometric assessments during spaceflight

12 months

12 in-flight assessments

Post-flight Follow-up

Participants are monitored for cognitive and structural brain changes after returning to Earth

1 month

2 visits (5 days and 30 days post-flight)

Treatment Details

Interventions

• Controls
• Spaceflight

Trial Overview The study examines how long-duration spaceflights (12 months) aboard the International Space Station affect cognitive abilities and brain structure compared to shorter missions (6 months and 2 months). It focuses on general cognition using a test battery and spatial cognition alongside changes in the hippocampus.

Participant Groups

Group I: No Intervention Experimental Treatment 1 Intervention

Subjects matched to 12-month astronauts that stay on Earth and are investigated at similar time points.

Group II: 6-Month Arm Experimental Treatment 1 Intervention

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.

Group III: 2-Month Arm Experimental Treatment 1 Intervention

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.

Group IV: 12-Month Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Aeronautics and Space Administration (NASA)

Collaborator

Trials

32

Recruited

1,900+

DLR German Aerospace Center

Collaborator

Trials

26

Recruited

5,900+

Charite University, Berlin, Germany

Collaborator

Trials

1,071

Recruited

3,739,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Human cognitive performance in spaceflight and analogue environments. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Performance During Confinement and Sleep Restriction in NASA's Human Exploration Research Analog (HERA). [2020]

3. England pubmed.ncbi.nlm.nih.gov

Persistent deterioration of visuospatial performance in spaceflight. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mental performance during short-term and long-term spaceflight. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Is dual-task performance necessarily impaired in space? [2017]

6. Germany pubmed.ncbi.nlm.nih.gov

Brains in space: the importance of understanding the impact of long-duration spaceflight on spatial cognition and its neural circuitry. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Cognitive performance aboard the life and microgravity spacelab. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Study protocol to examine the effects of spaceflight and a spaceflight analog on neurocognitive performance: extent, longevity, and neural bases. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of Spaceflight Medical Conditions' and Treatments' Potential Impacts on Behavioral Health and Performance. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise as potential countermeasure for the effects of 70 days of bed rest on cognitive and sensorimotor performance. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive neuroscience in space. [2020]