Canadian Forces Health Services
Ottawa, Ontario, K0A 1B0, Canada
Location status: Recruiting
NCT Number: NCT05474066
This study looks to investigate the cognitive effects associated with intense, military combat training regimens or so-called repetitive sub-concussive forces. Specifically, study participants will undergo cognitive testing in tandem with EEG recordings pre- and post-military training to assess cognition.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Ottawa, Ontario, K0A 1B0, Canada
Location status: Recruiting
Background Despite the high prevalence of cognitive issues in Veterans and active military personnel, there is relatively little understanding regarding the cognitive effects following intense, military training regimens designed to reflect a combat environment and blast exposure. Anecdotal evidence has shown that soldiers complain of cognitive issues post-training similar to those who have sustained brain trauma. Accordingly, this study looks to investigate the cognitive effects associated with intense, military combat training regimens or so-called repetitive sub-concussive forces. Specifically, study participants will undergo cognitive testing in tandem with EEG recordings pre- and post-military training to assess cognition.
Research Objective To assess the effects of repetitive, sub-concussive exposure (RSCE) on cognitive functioning and brain electrophysiology in Special Operation Forces (SOF) personnel. Furthermore, the relation between repetitive sub-concussive exposure and symptoms will be clarified.
Participants and Procedure 20 SOF members will complete a symptom profile, a vestibular ocular motor screening (VOMS), ImPACTTM Cognitive Testing and VoxNeuroTM Electroencephalogram (EEG) assessment pre-and post-training to assess cognitive functioning in the following domains: attention and concentration, working memory, and information processing. Investigators will look for correlations pre and post training
The cognitive assessment(s) to be taken are:
Test Descriptions
Biological Markers Measured (up to 7) ● N100/P200 - Auditory and Visual Processing
● N400 - Language Comprehension (TBD)
Benefits and Military Significance Understanding the relationship between exposure to repetitive, sub-concussive impacts to behavioural symptomatology, vestibular ocular dysfunction, brain electrophysiology, and cognition to aid in early detection/prevention, treatment and prognostication of SOF members. Moreover, this study will lay the foundation for future research for years to come.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline and within 1 week of completion of 4 week training course
changes on selected event related potentials (ie N100, P200, N200, P300, N400) when testing attention, concentration, continuous visual memory, executive function and comprehension
Time frame: baseline and within 1 week of completion of 4 week training course
FDA cleared online tool for baseline and post-injury testing. It measures patient reported symptoms, visual and verbal memory, reaction time, and processing speed to help determine if a patient can safely return to activity.
Time frame: baseline and within 1 week of completion of 4 week training course
Vestibular Ocular Motor Screening (VOMS) consists of symptom reporting (eg headache, dizziness, nausea, and fogginess) ranging from 0 (none) to 10 (severe) after testing smooth pursuits, saccades (horizontal and vertical), convergence, Neer Point of Convergence (NPC) distance, horizontal VOR, vertical VOR, and visual motor sensitivity (VMS). For the purpose of this study, we will use the VOMS cutoff scores of ≥2 total symptom score on any VOMS subscale and/or ≥5 cm on NPC average distance
Contact information is provided by the study sponsor or research team.
Canadian Forces Health Services Centre Ottawa
Other
Pilot Trial Examining the Impact of Training Related Sub-Concussive Forces On Cognition and Selected Electroencephalogram Measures In Canadian Special Forces Members
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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