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

CompletedOBSERVATIONAL
Enrollment

103

Participants

Timeline

Start Date

November 9, 2018

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2022

Conditions
Concussion, BrainMotor Vehicle Accident
Interventions
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.

DIAGNOSTIC_TEST

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.

Trial Locations (1)

CB2 0QQ

Mr Stephen Kelleher, Cambridge

All Listed Sponsors
collaborator

Global Institute for Motorsport Safety (GIMSS) - Year 1

UNKNOWN

collaborator

Neurolign Technologies LLC (previously Neuro Kinetics Incorporated, NKI)

UNKNOWN

collaborator

Cambridge University Hospitals NHS (National Health Service) Foundation Trust

UNKNOWN

collaborator

Federation Internationale de l'Automobile - Year 2 onwards

UNKNOWN

lead

University of Cambridge

OTHER

NCT03844282 - Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return | Biotech Hunter | Biotech Hunter