ERP Changes Pre and Post Military Changes
ConditionBrain Concussion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCanadian Forces Health Services Centre Ottawa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
● 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
Disqualifiers
● 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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ERP Testing
Device* Attention \& Concentration: * Continuous Visual Memory Test (CVMT): * Flanker Task: * Hayling Test:
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Pre and Post Training1 intervention
Trial outcomes
Primary outcomes
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
Time frame
baseline and within 1 week of completion of 4 week training courseSecondary outcomes
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.
Time frame
baseline and within 1 week of completion of 4 week training course2
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
Time frame
baseline and within 1 week of completion of 4 week training courseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov