None listed
Conditions
Brief summary
This study is a randomised, controlled, crossover, non-pharmacological, unblinded pilot trial. Participants will complete two experimental trials during which they will perform either a soccer heading or control kicking task. Brain structure, function and chemistry will be assessed ~30-minutes later using advanced neuroimaging techniques. Individuals will also provide blood samples and complete cognitive function tests at regular intervals post-intervention. Trials will be conducted at Neuroscience Research Australia (NeuRA), Randwick, NSW. We hypothesise that reduced efficiency of brain function and neural viability will be detected relative to the control condition.
Interventions
A Subconcussive Soccer Heading Task (SSHT)
A JUGS Soccer Machine will be used to launch FIFA regulation size 5 soccer balls inflated to 13 psi at a speed of 40 km·h-1. Participants will perform 20 soccer headers at 1-minute intervals from a distance of 12 meters. The clinical trial coordinator will instruct participants to hit the ball with their forehead and aim at a target 15 meters in front of them. The launch angle will initially be set at 40° to the horizontal; however, a ‘practice’ launch
A Subconcussive Soccer Heading Task (SSHT) A JUGS Soccer Machine will be used to launch FIFA regulation size 5 soccer balls inflated to 13 psi at a speed of 40 km·h-1. Participants will perform 20 soccer headers at 1-minute intervals from a distance of 12 meters. The clinical trial coordinator will instruct participants to hit the ball with their forehead and aim at a target 15 meters in front of them. 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 individual’s preference. Intervention fidelity will be measured via personalised Impact Monitoring Mouthguard sensors (Prevent Biometrics, Edina, MN, USA) The intervention will be administered on one occasion, only; with participants randomly allocated to complete the intervention or comparator condition first (see below). The intervention task will take 20 minutes to complete, with 3 hours for further assessments and 30 minutes for travel between the intervention site and data collection site. Each condition will be separated by a washout period of at least 7 days.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
- Healthy individuals - More than or equal to 5 years of soccer heading experience; that is, more than or equal to 5 full seasons of play and(or) training (with heading) the most recent of which was completed in the last 2 years. - Proficient in English and able to provide informed consent
Exclusion criteria
(a) A self-reported head, neck, face and/or eye injury (including concussion; as assessed via the Concussion History Questionnaire in the last 12 months (b) A current, self-reported sports injury (any type) (c) A self-reported history of neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness >15-minutes, spinal cord injury, stroke) (d) Implantation of a cochlear device, cardiac pacemaker, intracardiac lines, medical fusion device, neurostimulator or metal plates (in the head) (e) Use of dental braces or eyeglasses (contact lenses permitted) (f) A contraindication to MRI (that is not already excluded in another criterion) (i.e., body and(or) facial piercings that cannot easily be removed, a drug infusion pump that cannot easily be removed) (g) 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 or at the medical doctor’s discretion, except, mild to moderate depression (score <20 on the Beck Depression Inventory [BDI] or mild to moderate anxiety (score <16 on the Beck Anxiety Inventory [BAI] (h) A history of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire (PHQ)-9 (i) 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 (j) Inability to refrain from consuming alcohol (24 hours) and caffeine (12 hours) prior to each experimental trial (k) Inability to refrain from using anti-inflammatory medications (4-days) prior to each experimental trial (e.g., non-steroidal anti-inflammatories [NSAIDs], such as Ibuprofen, Naproxen, Diclofenac; and corticosteroids, such as Prednisolone). (l) 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 as confirmed by a negative urine drug screen (UDS) (DrugCheck® NxStep Onsite Urine Test Cup) (m) Pregnant or lactating. All female volunteers of childbearing potential will be required to complete a urine pregnancy test (Human Chorionic Gonadotrophin [hCG] Cassette, AlereTM). Females of childbearing potential must also agree to use a reliable form of contraception while participating in this project. (n) Current use of platelet active agents such as aspirin, ticagrelor, clopidogrel and prasugrel, warfarin and direct oral anticoagulants (DOACs)
Outcome results
None listed