RESCUE-RACERResearch Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
Data Collection
Collected from today forward - ProspectiveBrain Injuries, Traumatic+8
+ Brain Concussion
+ Brain Diseases
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: November 9, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.103 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location