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Brain ConcussionNCT05474066

ERP Changes Pre and Post Military Changes

An observational study of Brain Concussion, run by Canadian Forces Health Services Centre Ottawa at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Brain Concussion
What is being tested?
ERP Testing
Type of treatment
Medical device
How many people
20 participants
Where
1 siteCanada
Study dates
1 Aug 2022to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

Study population: A sample will be recruited from a group of 20 CAF SOF personnel ages 18-65 will be assessed twice: pre and post-special forces military training. All members enrolled in this training will be invited to participate in the study. Testing periods will be about 4 weeks apart, with post training testing within 1 week of conclusion of the exercise. Patients will be recruited from within the Canadian Special Operation Forces community

Who may be able to join

  • ● Male or female between 18 and 65
  • Normal or corrected to normal vision and hearing (Note: If the patient has hearing aids or wears glasses, they are still able to complete the assessment. They will need to remove hearing aids for the Attention \& Concentration and Information Processing test)
  • Sit still for 10-15 minutes
  • Understand basic instructions of cognitive tests

Who cannot join

  • ● Metal plates under their scalp that cross the midline
  • Taking epilepsy medications
  • History of neurologic or neuropsychiatric disorder prior to concussion in controls
  • Taking psychotropic medications
  • History of complete deafness
  • Supplements or performance enhancing drugs that can affect brain function

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Canadian Forces Health Services

    Ottawa, Ontario, K0A 1B0

    Gaurav Gupta, 6139451551, gaurav.gupta@forces.gc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Pilot Trial Examining the Impact of Training Related Sub-Concussive Forces On Cognition and Selected Electroencephalogram Measures In Canadian Special Forces Members

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.

Read the detailed description

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:

  1. ImPact Cognitive Testing
  2. VoxNeuro Assessment (EEG)
  3. Attention \& Concentration Test - 10min
  4. Continuous Visual Memory Test - 5min
  5. Flanker Test (Optional) - 10min
  6. Hayling Test (TBD - Currently only an English version available) - 10min Test Descriptions
  • Participants will keep logbooks looking at trauma exposure to help identify occupational vs non occupational causes, however given the intensity and length of the course significant non Paroccupational exposure is unlikely.
  • Blast Measurement will be monitored using a validated system of three worn blast gauges (Black-box Biometrics Inc.). These gauges - placed on the back of the helmet, non-firing shoulder, and chest - will be used to collect blast overpressure exposure levels above 0.5 psi at the location of the participant during the breaching events. Blast gauges will be issued to all participants prior to blast overpressure exposure and monitored throughout the duration of the study.
  • 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
  • ImPACT is an 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.
  • VoxNeuro Assessment:
  • Attention \& Concentration: An auditory oddball task where the participant is asked to identify the difference between one (1) or more auditory stimuli while EEG is recorded simultaneously to assess Attention and Concentration function at the neurophysiological level.
  • Continuous Visual Memory Test (CVMT): A visual task whereby participants are asked to differentiate between visual stimuli that have been previously presented to them and newly presented visual stimuli while EEG is recorded simultaneously to assess Memory function at the neurophysiological level.
  • Flanker Task: This test consists of participants identifying target stimulus while a target is flanked by non-target stimuli which correspond either to the same directional response as the target (congruent flankers), to the opposite response (incongruent flankers), or to neither (neutral flankers). The test is administered while EEG is recorded simultaneously to assess Executive Function and Response Inhibition at the neurophysiological level.
  • Hayling Test: This test consists of participants being aurally presented congruent and incongruent sentences; whereby, the congruent sentences are "normal" sentences with the final word being correct (e.g., "The pizza was too hot to eat"). In contrast, the incongruent sentences have the final word of a sentence being incorrect (e.g., The pizza was too hot to sing"). The test is administered while EEG is recorded simultaneously to assess Language Comprehension at the neurophysiological level. Biological Markers Measured (up to 7) ● N100/P200 - Auditory and Visual Processing
  • N100 ERP is a temporal and frontal component elicited by auditory stimuli. The response is associated with perception.
  • P200 ERP is mainly exhibited at the frontal and occipital lobes and represents higher order perceptual processes such as visual search, language, context information, memory and repetition effects. I.e. all processes modulated by attention.
  • N200 - Information Processing and Executive Function
  • N200 is a centro-cortical component associated with conscious stimuli detection (i.e. information processing and response inhibition) ● P300 - Attention and Memory
  • The P3a is a fronto-central component associated with attention orienting and is followed by the P3b, a centro-parietal component often linked to processes related to memory and attention allocation ● N400 - Language Comprehension (TBD)
  • N400 is a central component and acts as the normal brain response to semantic stimuli. For example, words, sign language, pictures, faces, smells. 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.
Being tested
ERP Testing
Keywords
erp, eeg, military
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERP TestingDevice

    • Attention \& Concentration:
    • Continuous Visual Memory Test (CVMT):
    • Flanker Task:
    • Hayling Test:
Study groups in NCT05474066
Study groupRoleWhat they receive
Pre and Post TrainingA sample will be recruited from a group of 20 CAF SOF personnel ages 18-65 will be assessed twice: pre and post-special forces military training. All members enrolled in this training will be invited to participate in the study. Testing periods will be about 4 weeks apart, with post training testing within 1 week of conclusion of the exercise. Patients will be recruited from within the Canadian Special Operation Forces community. Recruitment and study will take place starting in September 2022 and continue until complete which is estimated to be approximately 12 months. Participants will be made aware of the study through recruitment letter sent as part of their training package (Appendix A). They will be allowed questions prior to enrollment or at any point during participation.
Receives: Device: ERP Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Related Potential Changes

    changes on selected event related potentials (ie N100, P200, N200, P300, N400) when testing attention, concentration, continuous visual memory, executive function and comprehension

    Measured: baseline and within 1 week of completion of 4 week training course

Secondary outcomes (2)
  1. Impact Cognitive testing

    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.

    Measured: baseline and within 1 week of completion of 4 week training course

  2. VOMS

    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

    Measured: baseline and within 1 week of completion of 4 week training course

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474066
Sponsor's protocol ID
2022-016
Status last verified
Feb 2024
First submitted
19 Jul 2022
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Concussion, run by Canadian Forces Health Services Centre Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gaurav Gupta (6139451551, gaurav.gupta@forces.gc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Related Potential Changes (time frame: baseline and within 1 week of completion of 4 week training course). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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