Clinical trial NCT03844282: Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
Official title: Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Brain
Motor Vehicle Accident
Keywords: Concussion
mTBI
mild traumatic brain injury
motorsport
motor sport
racing
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Global Institute for Motorsport Safety (GIMSS) - Year 1
name: Neurolign Technologies LLC (previously Neuro Kinetics Incorporated, NKI)
name: Cambridge University Hospitals NHS (National Health Service) Foundation Trust
name: Federation Internationale de l'Automobile - Year 2 onwards
First posted: 2019-02-18
Enrollment: 103
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligibility Criteria-CArBON; all competitors associated with the TOCA\* series or contracted by Aston Martin Racing (AMR)

Eligibility Criteria-CARS; following exposure to a potentially concussive event sustained during motorsport activity: a) All competitors associated with the TOCA series or contracted by AMR b) Any competitive motorsports competitors who are referred to the Chief Investigator

\*'TOCA' is a motorsports event package based in the UK (registered as a Patient Identification Centre, PIC). In 2019, TOCA consists of 6 semi-/professional racing series (3 adult-British Touring Car Championship (BTCC), Porsche Carrera Cup GB, Michelin Ginetta GT4 Supercup; 1 mixed age-Renault UK Clio Cup (17 years+); 2 adolescent (14-17 years)-Simpson Race Products Ginetta Junior Championships, British Formula 4 Championship; certified by Fédération Internationale de l'Automobile, FIA; powered by Ford).In 2020, Renault is replaced by the Mini Challenge series.

Brief summary: RESCUE-RACER is jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.

The RESCUE-RACER programme evaluates motorsports competitors at baseline (CArBON) and post-injury (CARS). The CArBON study (Competitor Assessment at Baseline; Ocular, Neuroscientific) collects a battery of neuroscientific data in a baseline assessment. The CARS study (Concussion Assessment and Return to motorSport), repeats the CArBON battery throughout the recovery period in competitors who sustain a potentially concussive event during motorsport.

The primary outcome of the RESCUE-RACER programme is to establish the natural history of concussive symptoms and signs in motorsport competitors using a comprehensive neuroscientific battery. The standard clinical assessment of concussive symptoms will be correlated with objective clinical scoring, in addition to neurocognitive and neuropsychological assessments. Advanced brain imaging with MRI will be used to further characterize head injuries in motorsport. Finally, salivary biomarkers will be collected to monitor the measurable biological effects of a potentially concussive event immediately following injury and through recuperation in the recovery period.

The secondary outcome is investigation of a novel diagnostic tool for concussion, in the form of a 3D head-mounted display and eye tracking system capable of assessing ocular, vestibular and reaction time (OVRT) functions (the I-PAS device, now re-named Dx 100).

The results of RESCUE-RACER will form an evidence base for medical decision-making track side after a potentially-concussive incident and will advise on clinic management of motorsports concussion, including the important 'return-to-race' decision.


Eligibility criteria: Inclusion criteria (CArBON and CARS)

a) Competitive motorsports participants

Additional inclusion criteria - CARS only

1. Exposure to a potentially concussive event during motorsport activity OR a diagnosis of concussion during motorsport made by an experienced clinician \<3 weeks prior to referral.
2. Mental capacity to consent to study participation

Exclusion criteria (CArBON) Prior severe or moderate traumatic brain injury, diagnosis of mild traumatic brain injury or concussion within the last 6 months, symptoms of head injury at time of enrolment

Exclusion criteria - (CArBON and CARS)

Absolute exclusion criteria

1. Age \<16 years
2. Ongoing injuries so severe as to preclude study enrolment
3. Recent (within the last 4 months) or current involvement in a research study involving administration of trial medication

Possible exclusion criteria i. Recent (within the last 4 months) or current involvement in an observational research study (decision made by the enrolling study team member based upon the study's time commitments and the likelihood and feasibility of the participant attending future RESCUE-RACER assessments) ii. For MRI imaging only; metal implants or exposure to metal foreign objects (such as welding) - as per local policy (at the University of Cambridge Wolfson Brain Imaging Centre, WBIC).

Primary outcomes:
measure: Change in SCAT5 decision scores
timeFrame: Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
measure: Change in computerised neurocognitive assessment scores
timeFrame: Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
measure: Change in computerised neuropsychological assessment scores
timeFrame: Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
measure: Change in the brain's microstructural architecture, or functional changes in the brain
timeFrame: Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
measure: Change in salivary biomarker levels
timeFrame: Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
Secondary outcomes:
measure: Altered performance in ocular, vestibular and reaction time (OVRT) assessment utilising the I-PAS/Dx100 device
timeFrame: Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Mr Stephen Kelleher
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: Peter J Hutchinson, MB BS FRCS (Surg Neurol)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deakin ND, Suckling J, Hutchinson PJ. Research Evaluating Sports ConcUssion Events-Rapid Assessment of Concussion and Evidence for Return (RESCUE-RACER): a two-year longitudinal observational study of concussion in motorsport. BMJ Open Sport Exerc Med. 2021 Jan 13;7(1):e000879. doi: 10.1136/bmjsem-2020-000879. eCollection 2021.