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Spaceflight Effects on Cognitive Functioning

N/A
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal, healthy volunteers (astronaut surrogates) - Astronaut surrogates will be matched for age and education relative to astronauts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

Study Summary

This trial looks at the effects of long-term spaceflight on the brain.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves spaceflight rather than medication or medical procedures on Earth, traditional side effects are not applicable. However, participants may experience effects related to extended time in microgravity such as muscle atrophy or bone density loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am healthy and my age and education match those of astronauts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain-Derived Neurotropic Factor (BDNF)
Cognitive performance
Local task activation Cognition
+3 more
Secondary outcome measures
Insulin-like Growth Factor 1 (IGF-1)
Interleukin (IL)-1
Interleukin (IL)-10
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: No InterventionExperimental Treatment1 Intervention
Subjects matched to 12-month astronauts that stay on Earth and are investigated at similar time points.
Group II: 6-Month ArmExperimental Treatment1 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 ArmExperimental Treatment1 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 ArmExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,048 Total Patients Enrolled
National Aeronautics and Space Administration (NASA)FED
24 Previous Clinical Trials
1,726 Total Patients Enrolled
DLR German Aerospace CenterOTHER
24 Previous Clinical Trials
5,774 Total Patients Enrolled

Media Library

Controls Clinical Trial Eligibility Overview. Trial Name: NCT04856410 — N/A
Cognitive Functioning Research Study Groups: 2-Month Arm, 6-Month Arm, 12-Month Arm, No Intervention
Cognitive Functioning Clinical Trial 2023: Controls Highlights & Side Effects. Trial Name: NCT04856410 — N/A
Controls 2023 Treatment Timeline for Medical Study. Trial Name: NCT04856410 — N/A
Cognitive Functioning Patient Testimony for trial: Trial Name: NCT04856410 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period still open for this clinical research?

"Evidence from clinicaltrials.gov reveals that the trial is not currently recruiting patients. Originally posted on August 1st 2021, it was last updated on September 30th 2022. However, 8 other trials are now seeking participants to enrol in their respective research programmes."

Answered by AI

What is the endgame of this clinical trial?

"The primary purpose of this clinical investigation, monitored for around two months before and after space flight, is to assess spatial cognition performance. Secondary objectives include alterations in Interleukin (IL)-10 levels, Tumor Necrosis Factor a (TNFa), and Insulin-like Growth Factor 1 (IGF-1)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What site did they apply to?
Johnson Space Center (JSC)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I've tried stem cells, ketamine, and etanercept to no avail.
PatientReceived 1 prior treatment
Recent research and studies
~27 spots leftby Dec 2033