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.
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
- Recruiting
Canadian Forces Health Services
Ottawa, Ontario, K0A 1B0
Gaurav Gupta, 6139451551, gaurav.gupta@forces.gc.ca
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:
- ImPact Cognitive Testing
- VoxNeuro Assessment (EEG)
- Attention \& Concentration Test - 10min
- Continuous Visual Memory Test - 5min
- Flanker Test (Optional) - 10min
- 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.
- Conditions
- Brain Concussion
- 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 group | Role | What they receive |
|---|---|---|
| Pre and Post Training | 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. 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.
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)
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
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.
- First posted26 Jul 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Canadian Forces Health Services Centre Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Gupta, Canadian Forces Health Services Centre Ottawa
- Investigators
- Gaurav Gupta, Principal investigator, Gaurav Gupta MPC
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Examining the Impact of Training Related Sub-Concussive Forces On Cognition and Selected Electroencephalogram Measures In Canadian Special Forces Members
- ClinicalTrials.gov ID
- NCT05474066
- Acronym / sponsor ID
- 2022-016
- Conditions
- Brain Concussion
- Keywords
- erp, eeg, military
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Canadian Forces Health Services Centre OttawaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- ImPact Cognitive Testing
- VoxNeuro Assessment (EEG)
- Attention \& Concentration Test - 10min
- Continuous Visual Memory Test - 5min
- Flanker Test (Optional) - 10min
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre and Post Training | – | Device: ERP TestingA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (4 listed)
- ● Male or female between 18 and 65
Key exclusion criteria (6 listed)
- ● Metal plates under their scalp that cross the midline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERP Testing* Attention \& Concentration: * Continuous Visual Memory Test (CVMT): * Flanker Task: * Hayling Test: | Device | Pre and Post Training |
Primary outcome
Event Related Potential Changes
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
2 secondary outcomes
Impact Cognitive testing
Time frame: baseline and within 1 week of completion of 4 week training course
VOMS
Time frame: baseline and within 1 week of completion of 4 week training course
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaurav Gupta principal investigator
Gaurav Gupta MPC
1 site in 1 country: see every site and its status.
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.