Operational Performance Effects and Neurophysiology in Partial Gravity (NCT06736652) | Clinical Trial Compass
CompletedNot Applicable
Operational Performance Effects and Neurophysiology in Partial Gravity
France12 participantsStarted 2023-03-01
Plain-language summary
Aim 1: Characterize and quantify changes in operationally-relevant sensorimotor and vestibular performance as a function of gravitational load.
Aim 2: Characterize and quantify changes in physiology-particularly in brain function and autonomic activation during behavioral performance-as a function of gravitational load.
Aim 3: Develop a model to predict behavioral performance and neurophysiological responses under different gravitational loads based on preflight ground testing data.
(Hyp1) The investigators predict a monotonic but non-linear relationship between operational performance (grappling / postural sway) and gravitational load, with larger departures from 1g leading to more impaired performance.
(Hyp2) The investigators predict a similar relationship between gravity load and physiological measures, with larger departures from 1g leading to larger changes in prefrontal and vestibular cortex, and autonomic nervous system activation.
(Hyp3) Ground-based challenges to the vestibular system will induce detectable postural sway and neurophysiological responses. The amplitude of these responses and/or adaptation rates to the challenges (i.e., indicators of individual "sensitivity" to such provocations) will (3a) help predict neurophysiological responses in-flight, and (3b) help predict behavioral performance in flight.
Who can participate
Age range
30 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy 30-55-year-olds
* Willingness and ability to participate in flights without motion sickness medications.
* Any Novespace requirements
Exclusion Criteria:
* Failure to meet medical criteria and provide certification of fitness for flight to NOVESPACE (i.e., NOVESPACE Parabolic Flight Medical Aptitude Certificate) completed by their medical doctor or an Authorized Medical Examiner
* Certain heart and lung conditions
* Dizziness
* Certain inner ear conditions
* Severe motor disability or impaired bone density
* Psychosis
* Mental disability prohibiting emergency evacuation.
* Epilepsy
* Certain neurological diseases
* Fear of heights/flying
* Debilitating anxiety and panic attacks
* Claustrophobia
* Women who are pregnant
* Certain gastrointestinal conditions
* Those taking certain medications. An individual's overall medical fitness for flight is assessed and certified by a medical doctor or Authorized Medical Examiner.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.