Determining Which Regions of the Brain Are Active During Flight Simulation at Separate Timepoints… (NCT06606925) | Clinical Trial Compass
RecruitingNot Applicable
Determining Which Regions of the Brain Are Active During Flight Simulation at Separate Timepoints During Training
United States150 participantsStarted 2023-09-19
Plain-language summary
The overall objective is to identify the cognitive circuits associated with military aviator performance by analyzing what anatomic regions of the brain are functionally "active" (neuronal circuit) while being performing virtual flight simulations, the Precision Instrument Control Task (PICT). The flight simulation test will be conducted at two separate timepoints while the subject is receiving a Functional Magnetic Resonance Imaging (fMRI) scan to evaluate which anatomic and functional brain function is associated with precise performance. By scanning at multiple time points we aim to quantify changes in functional and anatomic connectivity that occur throughout the course of training.
Who can participate
Age range
18 Years – 54 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:
* Active Duty Military Pilots (Instructor Pilot Trainees or Remote Piloted Aircraft Trainees)
* Age 18-54 years
* Biological male or female
Exclusion Criteria:
* Age \< 18 years
* Age \> 60 years
* Non-active-duty members
* History of recurrent migraine headaches requiring chronic suppressive medication or prescription drug intervention more frequently than once per year.
* History of head trauma or traumatic brain injury with any loss of consciousness or with confusion or amnesia of greater than five minutes.
* History of eye trauma related to a metallic object unless the presence of residual metal has been previously excluded by x-ray.
* Pregnancy
* History of significant neurological disease including cerebrovascular disease, demyelinating disease, or infections of the central nervous system (encephalitis, meningitis).
* History of medical conditions with potential neurological involvement such as obstructive sleep apnea, autoimmune disorders, etc.
* History of seizures since age six.
* Claustrophobia or intolerance of the MRI without medication.
* Any medical contraindication to MRI (ex: foreign bodies, non-MRI compatible pacemaker, metal devices).
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.
What they're measuring
1
Flight simulation scores of responses (reaction times and latency)
Timeframe: From enrollment to the end of treatment at 30 months