Status:
COMPLETED
Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Global Institute for Motorsport Safety (GIMSS) - Year 1
Neurolign Technologies LLC (previously Neuro Kinetics Incorporated, NKI)
Conditions:
Concussion, Brain
Motor Vehicle Accident
Eligibility:
All Genders
16+ years
Brief 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 (CAr...
Eligibility Criteria
Inclusion
- Inclusion criteria (CArBON and CARS)
- a) Competitive motorsports participants
- Additional inclusion criteria - CARS only
- 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.
- 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
- Age \<16 years
- Ongoing injuries so severe as to preclude study enrolment
- 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).
Exclusion
Key Trial Info
Start Date :
November 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03844282
Start Date
November 9 2018
End Date
December 31 2022
Last Update
December 12 2023
Active Locations (1)
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1
Mr Stephen Kelleher
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ