Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return

Concussion, Brain Clinical Trial

— RESCUE-RACER  

Official title:

Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844282
• Other study ID #: A094577
• Status: Completed
• Start date: November 9, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain
• Motor Vehicle Accident

Intervention

Diagnostic Test:
• Clinical assessment (SCAT5)
The SCAT5 is a standardized tool for evaluating sports-related concussions designed for use by physicians and licensed healthcare professionals in patients aged 13 years and above. It is a ten minute paper-based assessment which includes immediate and office/off-field assessments. SCAT5 incorporates the Maddocks' questions, Glasgow Coma Scale (GCS), cervical spine assessment and symptom evaluation, in addition to cognitive and neurological screening.
• ImPACT
ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing) is a neurocognitive assessment administered online or using desktop software in a controlled environment. ImPACT has two components: baseline testing and post-injury testing, both of which are used to determine if a patient can safely return to sporting activity post-concussion.

Behavioral:
• CANTAB
Originally developed at the University of Cambridge, the Cambridge Neuropsychological Test Automated Battery (CANTAB) platform includes highly sensitive, precise and objective measures of cognitive function, correlated to neural networks. These tests have demonstrated sensitivity to detecting changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control. The CANTAB touchscreen battery (www.camcog.com) will be utilised to perform neuropsychological assessments within RESCUE-RACER, whose study-specific protocol may include assessments of: Spatial Working Memory (working memory and strategy), Reaction Time (processing and psychomotor speed), Paired Associated Learning and the Multi-Tasking Test.

Diagnostic Test:
• I-PAS/Dx100
I-PAS™ (now re-named Dx 100) is a portable, head-mounted, neural functional assessment tool. With its integrated clinical eye tracking and digital display, the FDA has cleared (K171884) fourteen tests and an unmatched list of variables for clinical use for a variety of conditions. This utility of this device will be investigated for motorsport-related concussion.

Biological:
• Saliva sample
Micro RNA's (miRNA's) are easily measured in saliva and have proven to have both diagnostic and prognostic use in sports-related concussion across the adolescent and adult populations, with levels persisting for some weeks after the concussive event. RESCUE-RACER will collect saliva samples for analysis of biomarkers of concussion, which may include miRNA and other markers of injury.

Other:
• fMRI
RESCUE-RACER participants will be invited to complete a functional MRI scan, whose 90-minute protocol may include: multi-parametric mapping (MPM), susceptibility weighted imaging (SWI), diffusion weighted imaging (DWI), proton spectroscopy and functional MRI (fMRI) with blood oxygenation-level dependent contrast (BOLD), completed at 7T (Tesla), or 3T if this is not possible.

Locations

Country	Name	City	State
United Kingdom	Mr Stephen Kelleher	Cambridge	Cambridgeshire

Sponsors (5)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge University Hospitals NHS (National Health Service) Foundation Trust, Federation Internationale de l'Automobile - Year 2 onwards, Global Institute for Motorsport Safety (GIMSS) - Year 1, Neurolign Technologies LLC (previously Neuro Kinetics Incorporated, NKI)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SCAT5 decision scores	Change in performance on the Sports Concussion Assessment Tool 5 (SCAT5) from baseline to follow-up, as measured by sections of the assessment: Symptoms - number (range 0-22) and severity (each rated as 0-6), summed to form a symptom severity score (range 0-132), with higher scores indicating worse symptoms *For more information please see Step 2: Symptom Evaluation at link below*; Orientation score; Immediate memory score; Concentration score; Neurological examination; Number of balance errors; Delayed recall score; Which are combined to form a Decision (please see Step 6 at https://bjsm.bmj.com/content/bjsports/early/2017/04/26/bjsports-2017-097506SCAT5.full.pdf).	Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
Primary	Change in computerised neurocognitive assessment scores	Change in neurocognitive performance from baseline to follow-up, as measured by the Immediate Post-concussion Assessment and Cognitive Testing tool (ImPACT, please see https://impacttest.com/).; This previously-validated assessment consists of the following sections: Attention (including processing); Memory (verbal and visual recognition; visual working); Visual motor speed; Learning; Impulse control (response inhibition); Delayed memory (repeat of verbal and visual tasks in 2); Which are combined to form Composite scores, whose calculation is defined in the ImPACT's Administration & Interpretation Manual (available on request).	Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
Primary	Change in computerised neuropsychological assessment scores	Change in neuropsychological performance from baseline to follow-up, as measured by CANTAB Connect Research, the world's most validated, precise and reliable research software (please see http://www.cambridgecognition.com/products/cognitive-research/).; This previously-validated assessment software consists of the following sections: Attention (processing and psychomotor speed); Memory (visual episodic); Executive function and decision-making (working memory and strategy; planning).; Each assessment produces a number of outputs, as detailed in the CANTAB Connect Research Overview Document (available on request).	Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
Primary	Change in the brain's microstructural architecture, or functional changes in the brain	Change in the brain's microstructural architecture, or functional changes in the brain, from baseline to follow-up as measured by: High-resolution structural imaging - disruption of usual cerebral architecture (i.e. volume of sub/cortical structures); Susceptibility-weighted imaging (SWI) - signal alteration; Diffusion-weighted imaging (DWI) - voxel intensity; Resting-state functional MRI (fMRI) - changes in blood oxygenation level; Proton spectroscopy	Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
Primary	Change in salivary biomarker levels	Change in the levels of salivary biomarkers from baseline to follow-up as potentially measured by markers of: Neuronal injury - such as neurofilament light chain (NFL); Glial injury - such as S100B (a calcium-binding peptide); Epigenetic effects - as measured by micro RNA levels (miRNA); Neurofibrillary degeneration - as measured by tau.	Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
Secondary	Altered performance in ocular, vestibular and reaction time (OVRT) assessment utilising the I-PAS/Dx100 device	The applicability of OVRT assessment as a diagnostic tool for motorsport concussion will be investigated by correlating changes in OVRT performance at baseline to OVRT performance following a clinical diagnosis of concussion or participation in motorsport activity. The assessment will be conducted with a portable head-mounted 3D display (please see http://neurolign.com/our-technology/, previously https://www.neuro-kinetics.com/products/).; Alteration in OVRT performance will be measured using: Ocular tests - saccades (vertical, horizontal, predictive, self-paced, memory-guided and anti-), smooth pursuit, optokinetic reflex, vergence, light reflex; Vestibular tests - subjective visual vertical; Reaction time assessments - auditory, visual; The I-PAS/Dx100 training manual is available on request (publication of further assessment details is subject to patents and/or copyright).	Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)

External Links

•   RESCUE-RACER Facebook account
•   RESCUE-RACER Instagram account
•   RESCUE-RACER published study protocol
•   RESCUE-RACER study website
•   RESCUE-RACER Twitter account