Brain Scans for Cognitive Functioning

(fMRI Pilots Trial)

Overseen By Ayla Ulfberht, Research Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Geneva Foundation

Must not be taking: Chronic migraine medications

Disqualifiers: Migraine, Head trauma, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Paul Sherman, MD

Principal Investigator

59th Medical Wing Science and Technology

Eligibility Criteria

This trial is for individuals who are being trained in military aviation and will participate in a study involving virtual reality flight simulation. The key requirement is that they must be available for brain scans at two different times during their training.

Inclusion Criteria

Active Duty Military Pilots (Instructor Pilot Trainees or Remote Piloted Aircraft Trainees)

I am either a biological male or female.

Exclusion Criteria

I am over 60 years old.

I am under 18 years old.

Non-active-duty members

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging and Simulation

Initial anatomic imaging and fMRI with virtual reality flight simulator scan

1 day

1 visit (in-person)

Repeat Imaging and Simulation

Repeat testing performed at approximately 2 months after initial scan

2 months

1 visit (in-person)

Follow-up

Participants are monitored for changes in brain activity and anatomy over time

26 months

Treatment Details

Interventions

• fMRI with virtual reality flight simulator

Trial Overview The study aims to determine which parts of the brain are active during flight simulation by using fMRI technology while participants engage in a virtual reality task designed to mimic flying an aircraft.

Participant Groups

Group I: Functional (fMRI) and anatomic MRI imaging a two timepoints during pilot virtual reality simulation Experimental Treatment 1 Intervention

Initial anatomic imaging and fMRI with virtual reality flight simulator scan with repeat testing performed at approximately 2 months (+/- 1 month) after initial scan.

Who Is Running the Clinical Trial?

The Geneva Foundation

Lead Sponsor

Trials

39

Recruited

13,700+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+