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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 belowSelect...
I am healthy and my age and education match those of astronauts.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
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 moreSecondary outcome measures
Insulin-like Growth Factor 1 (IGF-1)
Interleukin (IL)-1
Interleukin (IL)-10
+4 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility 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.I have significant hearing loss in both ears.You have a dental brace that cannot be removed.I experience ringing in my ears.You have foreign objects in your body that cannot be removed.You are pregnant or could become pregnant during the study.You have a medical device, such as a pump, that delivers medication.I am healthy and my age and education match those of astronauts.You have a pacemaker or internal defibrillator implanted in your body.I am a female, either an astronaut or similar, and cannot be pregnant during space missions.I have tattoos or permanent makeup.You have a hearing device implanted in your ear.You have an intrauterine contraceptive device (IUD) that cannot be used during an MRI.
Research Study Groups:
This trial has the following groups:- Group 1: 2-Month Arm
- Group 2: 6-Month Arm
- Group 3: 12-Month Arm
- Group 4: No Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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