None listed
Conditions
Brief summary
Background: Youth aged 14–24 years’ experience more concussions than any age group in Australia, coinciding with a critical neurodevelopmental period. The debilitating signs and symptoms interfere with school, sport, and daily activities. In 30% of cases patients have persistent and intractable effects lasting months to years, affecting mental health and impairing quality of life. Problem: There is a scarcity of effective treatments to mitigate and prevent the effects of a concussion. Australians, The Australian Senate, and international research groups are urging scientific investigations into clinical solutions. Solution: This project seeks to accelerate clinical trials in novel neuroprotective strategies. It will assess the potential and feasibility of an innovative and safe standardised soccer heading model to establish proof-of-concept for neuroprotective strategies in up to 80 male and female youth. This project is informed by a previous clinical pilot trial led by CI Delang. Impact: The clinical research model will facilitate rapid determination of proof-of-concept neuroprotective strategies in future trials, which our team of neurologists, physicians, dietitians, exercise physiologists, physiotherapists, biomedical engineers and statisticians are expertly positioned to conduct.
Interventions
Intervention: Soccer Heading Task
Participants will be instructed to stand 40 ft (~12 m) away from a JUGS Soccer Machine in an outdoor field. The machine will be used by an experience trial coordinator to launch weight-matched FIFA regulation size 5 soccer balls inflated to 13 psi at a speed of 25 mi·h-1 (~40 km·h-1). The launch angle will initially be set at 40° to the horizontal; however, a ‘practice’ launch, during which participants will observe the trajectory of the ball (without heading it
Intervention: Soccer Heading Task Participants will be instructed to stand 40 ft (~12 m) away from a JUGS Soccer Machine in an outdoor field. The machine will be used by an experience trial coordinator to launch weight-matched FIFA regulation size 5 soccer balls inflated to 13 psi at a speed of 25 mi·h-1 (~40 km·h-1). The launch angle will initially be set at 40° to the horizontal; however, a ‘practice’ launch, during which participants will observe the trajectory of the ball (without heading it), will be performed (and repeated if required) to calibrate this to each participant’s preference. Participants will then perform 10 soccer headers at 1-minute intervals. Individuals will be instructed to hit the ball with their forehead and aim at a target 15 m in front of them. If a header is unsuccessful (i.e., there is no contact between the head and the ball), another ball will be launched within the 1-minute interval (this procedure will be repeated if required until a successful header occurs). As such, every participant will complete exactly 10 headers, as observed by the trial coordinator, ensuring intervention fidelity. The intervention will be administered on one occasion, only; with participants randomly allocated to complete the intervention or comparator condition (see below).
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
14 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
Healthy males and females (~50% of each) with greater than or equal to 2 years of soccer heading experience (to ensure safe and controlled head impacts).
Exclusion criteria
(a) A self-reported head, neck, face and/or eye injury (including concussion; as assessed via questions 2 and 3 of the Concussion History Questionnaire in the last 6 months (b) A current, self-reported injury (any type) that requires some degree of medical intervention (e.g., RICE, pain-relief medication) (c) A self-reported history of neurological disorders (e.g., seizure disorders, spinal cord injury, stroke) (d) A history of a major psychiatric disorder within the previous 12 months, as per the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria (e) Current use of platelet-active agents such as aspirin, ticagrelor, clopidogrel and prasugrel, warfarin and direct oral anticoagulants (DOACs) (f) Inability to avoid soccer heading or any other activity involving head impacts (e.g., contact sports) 7 days prior to and while participating in this project (g) Inability to refrain from consuming alcohol (24 hours) and caffeine (12 hours) prior to each experimental trial (h) Inability to refrain from using central nervous system (CNS) active drugs (i.e., cocaine, cannabis, amphetamines, methamphetamine, benzodiazepines, methadone, opioids, oxycodone, barbiturates) 7 days prior to and while participating in this project (i) Pregnant or lactating, as indicated by self-report of such and last menses (j) Use of eyeglasses (contact lenses permitted)
Outcome results
None listed