Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return (RESCUE-RACER)

University of Cambridge

Status: Completed

Conditions: Motor Vehicle Accident; Concussion, Brain

Treatments: Diagnostic Test: I-PAS/Dx100; Other: fMRI; Diagnostic Test: ImPACT; Behavioral: CANTAB; Biological: Saliva sample; Diagnostic Test: Clinical assessment (SCAT5)

Study type: Observational

Funder types: Other

Identifiers

NCT03844282

A094577

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

103 participants in 2 patient groups

CArBON (baseline)

Description:

The RESCUE-RACER programme is formed of two studies; baseline (CArBON) and one post-injury (CARS). At baseline the larger CArBON study involves completion of a thorough single baseline neuroscientific assessment of healthy motorsport competitors including clinical, neuropsychological, neurocognitive, biomarker and vestibulo-ocular assessments, in addition to MRI of the brain.

Treatment:

Diagnostic Test: Clinical assessment (SCAT5)

Behavioral: CANTAB

Diagnostic Test: ImPACT

Biological: Saliva sample

Other: fMRI

Diagnostic Test: I-PAS/Dx100

CARS (exposure to a potentially concussive event)

Description:

The RESCUE-RACER programme has a single post-injury study; after involvement in a potentially concussive event sustained during motorsport, CARS serially repeats the CArBON assessment battery in the immediate post-concussion recovery period. CARS participants will under-go post-exposure neuroscientific assessments immediately after injury and then at one, two and three weeks post-injury. If symptoms persist beyond this time, a further two assessments at monthly intervals will be offered.

Treatment:

Diagnostic Test: Clinical assessment (SCAT5)

Behavioral: CANTAB

Diagnostic Test: ImPACT

Biological: Saliva sample

Other: fMRI

Diagnostic Test: I-PAS/Dx100