RESCUE-RACERResearch Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveBlessures Cérébrales Traumatiques+8
+ Commotion cérébrale
+ Maladies du cerveau
Autre
Méthodes concernant des questions de recherche très spécifiques.Résumé
Date de début de l'étude : 9 novembre 2018
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.103 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 16 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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).
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site