Determining Which Regions of the Brain Are Active During Flight Simulation at Separate Timepoints During Training

NCT06606925 | Recruiting FDA Device

• 2 other identifiers: FWH20230088HMW.65.R22
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Performance

Keywords

Pilots; Flight Simulator; fMRI; Training; Cognitive Performance; Neuroergonomics; Military

Outcome Measures

Primary Outcomes (1)

• Flight simulation scores of responses (reaction times and latency)

  Assess the flight simulation scores of responses (reaction times and latency) to the anatomical and functional regions of the brain that react when performing corrective flight actions. This will occur by analyzing anatomical MRI and fMRI imaging data and correlate with simulator performance.

  From enrollment to the end of treatment at 30 months

Study Arms (1)

Functional (fMRI) and anatomic MRI imaging a two timepoints during pilot virtual reality simulation

EXPERIMENTAL

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

Diagnostic Test: fMRI with virtual reality flight simulator

Interventions

fMRI with virtual reality flight simulator DIAGNOSTIC_TEST

During this scan, the subject will be wearing the stereogenic goggles called the Visual System HD (NordicNeuroLab) mounted in the scanner via a headcoil that can be adjusted to the subject's comfort using the control arm and completely cover the eyes to prevent light exposure and to clearly visualize eye movement during the flight simulation. The subject will be using a visual response system with customized grips to simulate a stick and throttle in a jet cockpit while visualizing the flight simulation (PICT) in the goggles.

Functional (fMRI) and anatomic MRI imaging a two timepoints during pilot virtual reality simulation

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Active Duty Military Pilots (Instructor Pilot Trainees or Remote Piloted Aircraft Trainees)
• Age 18-54 years
• Biological male or female

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Geneva Foundation: lead
• 59th Medical Wing: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Joint Base San Antonio - Randolph &amp; Lackland

San Antonio, Texas, 78150, United States

RECRUITING

Related Publications (19)

• Grady CL, Rieck JR, Nichol D, Rodrigue KM, Kennedy KM. Influence of sample size and analytic approach on stability and interpretation of brain-behavior correlations in task-related fMRI data. Hum Brain Mapp. 2021 Jan;42(1):204-219. doi: 10.1002/hbm.25217. Epub 2020 Sep 30.

  PMID: 32996635 BACKGROUND

• Beer J, Dart TS, Fischer J, Kisner J. Pulmonary Effects from a Simulated Long-Duration Mission in a Confined Cockpit. Aerosp Med Hum Perform. 2017 Oct 1;88(10):952-957. doi: 10.3357/AMHP.4854.2017.

  PMID: 28923145 BACKGROUND

• Turner BO, Paul EJ, Miller MB, Barbey AK. Small sample sizes reduce the replicability of task-based fMRI studies. Commun Biol. 2018 Jun 7;1:62. doi: 10.1038/s42003-018-0073-z. eCollection 2018.

  PMID: 30271944 BACKGROUND

• Li CX, Patel S, Zhang X. Evaluation of multi-shell diffusion MRI acquisition strategy on quantitative analysis using multi-compartment models. Quant Imaging Med Surg. 2020 Apr;10(4):824-834. doi: 10.21037/qims.2020.03.11.

  PMID: 32355646 BACKGROUND

• Bhushan C, Haldar JP, Choi S, Joshi AA, Shattuck DW, Leahy RM. Co-registration and distortion correction of diffusion and anatomical images based on inverse contrast normalization. Neuroimage. 2015 Jul 15;115:269-80. doi: 10.1016/j.neuroimage.2015.03.050. Epub 2015 Mar 27.

  PMID: 25827811 BACKGROUND

• Gonzalez-Castillo J, Panwar P, Buchanan LC, Caballero-Gaudes C, Handwerker DA, Jangraw DC, Zachariou V, Inati S, Roopchansingh V, Derbyshire JA, Bandettini PA. Evaluation of multi-echo ICA denoising for task based fMRI studies: Block designs, rapid event-related designs, and cardiac-gated fMRI. Neuroimage. 2016 Nov 1;141:452-468. doi: 10.1016/j.neuroimage.2016.07.049. Epub 2016 Jul 27.

  PMID: 27475290 BACKGROUND

• Lynch CJ, Power JD, Scult MA, Dubin M, Gunning FM, Liston C. Rapid Precision Functional Mapping of Individuals Using Multi-Echo fMRI. Cell Rep. 2020 Dec 22;33(12):108540. doi: 10.1016/j.celrep.2020.108540.

  PMID: 33357444 BACKGROUND

• Tan ET, Shih RY, Mitra J, Sprenger T, Hua Y, Bhushan C, Bernstein MA, McNab JA, DeMarco JK, Ho VB, Foo TKF. Oscillating diffusion-encoding with a high gradient-amplitude and high slew-rate head-only gradient for human brain imaging. Magn Reson Med. 2020 Aug;84(2):950-965. doi: 10.1002/mrm.28180. Epub 2020 Feb 3.

  PMID: 32011027 BACKGROUND

• Tan ET, Hua Y, Fiveland EW, Vermilyea ME, Piel JE, Park KJ, Ho VB, Foo TKF. Peripheral nerve stimulation limits of a high amplitude and slew rate magnetic field gradient coil for neuroimaging. Magn Reson Med. 2020 Jan;83(1):352-366. doi: 10.1002/mrm.27909. Epub 2019 Aug 6.

  PMID: 31385628 BACKGROUND

• Foo TKF, Tan ET, Vermilyea ME, Hua Y, Fiveland EW, Piel JE, Park K, Ricci J, Thompson PS, Graziani D, Conte G, Kagan A, Bai Y, Vasil C, Tarasek M, Yeo DTB, Snell F, Lee D, Dean A, DeMarco JK, Shih RY, Hood MN, Chae H, Ho VB. Highly efficient head-only magnetic field insert gradient coil for achieving simultaneous high gradient amplitude and slew rate at 3.0T (MAGNUS) for brain microstructure imaging. Magn Reson Med. 2020 Jun;83(6):2356-2369. doi: 10.1002/mrm.28087. Epub 2019 Nov 25.

  PMID: 31763726 BACKGROUND

• Callan DE, Terzibas C, Cassel DB, Callan A, Kawato M, Sato MA. Differential activation of brain regions involved with error-feedback and imitation based motor simulation when observing self and an expert's actions in pilots and non-pilots on a complex glider landing task. Neuroimage. 2013 May 15;72:55-68. doi: 10.1016/j.neuroimage.2013.01.028. Epub 2013 Jan 26.

  PMID: 23357079 BACKGROUND

• Callan DE, Gamez M, Cassel DB, Terzibas C, Callan A, Kawato M, Sato MA. Dynamic visuomotor transformation involved with remote flying of a plane utilizes the 'Mirror Neuron' system. PLoS One. 2012;7(4):e33873. doi: 10.1371/journal.pone.0033873. Epub 2012 Apr 20.

  PMID: 22536320 BACKGROUND

• Durantin G, Dehais F, Gonthier N, Terzibas C, Callan DE. Neural signature of inattentional deafness. Hum Brain Mapp. 2017 Nov;38(11):5440-5455. doi: 10.1002/hbm.23735. Epub 2017 Jul 26.

  PMID: 28744950 BACKGROUND

• Gougelet RJ, Terzibas C, Callan DE. Cerebellum, Basal Ganglia, and Cortex Mediate Performance of an Aerial Pursuit Task. Front Hum Neurosci. 2020 Feb 14;14:29. doi: 10.3389/fnhum.2020.00029. eCollection 2020.

  PMID: 32116611 BACKGROUND

• Mehta RK, Parasuraman R. Neuroergonomics: a review of applications to physical and cognitive work. Front Hum Neurosci. 2013 Dec 23;7:889. doi: 10.3389/fnhum.2013.00889.

  PMID: 24391575 BACKGROUND

• Cisek P, Kalaska JF. Neural mechanisms for interacting with a world full of action choices. Annu Rev Neurosci. 2010;33:269-98. doi: 10.1146/annurev.neuro.051508.135409.

  PMID: 20345247 BACKGROUND

• Van de Putte E, De Baene W, Garcia-Penton L, Woumans E, Dijkgraaf A, Duyck W. Anatomical and functional changes in the brain after simultaneous interpreting training: A longitudinal study. Cortex. 2018 Feb;99:243-257. doi: 10.1016/j.cortex.2017.11.024. Epub 2017 Dec 12.

  PMID: 29291529 BACKGROUND

• DeYoe EA, Bandettini P, Neitz J, Miller D, Winans P. Functional magnetic resonance imaging (FMRI) of the human brain. J Neurosci Methods. 1994 Oct;54(2):171-87. doi: 10.1016/0165-0270(94)90191-0.

  PMID: 7869750 BACKGROUND

• Tesch PA, Hjort H, Balldin UI. Effects of strength training on G tolerance. Aviat Space Environ Med. 1983 Aug;54(8):691-5.

  PMID: 6626076 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Paul Sherman, MD

  59th Medical Wing Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Walker-Rodriguez, Program Manager, MSN

CONTACT

(210) 841-7258; katherine.c.walker-rodriguez.ctr@health.mil

Ayla Ulfberht, Research Coordinator

CONTACT

ayla.f.ulfberht.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective observational study. Subjects will undergo functional and anatomic magnetic resonance imaging a two timepoints during pilot training. Performance in flight simulator will be correlated with fMRI measurements of axonal anatomy and brain activity.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: September 19, 2023
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)