Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
- Conditions
- Concussion, BrainMotor Vehicle Accident
- Interventions
- Diagnostic Test: Clinical assessment (SCAT5)Diagnostic Test: ImPACTBehavioral: CANTABDiagnostic Test: I-PAS/Dx100Biological: Saliva sampleOther: fMRI
- Registration Number
- NCT03844282
- Lead Sponsor
- University of Cambridge
- 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 (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CArBON (baseline) ImPACT The RESCUE-RACER programme is formed of two studies; baseline (CArBON) and one post-injury (CARS). At baseline the larger CArBON study involves completion of a thorough single baseline neuroscientific assessment of healthy motorsport competitors including clinical, neuropsychological, neurocognitive, biomarker and vestibulo-ocular assessments, in addition to MRI of the brain. CArBON (baseline) Clinical assessment (SCAT5) The RESCUE-RACER programme is formed of two studies; baseline (CArBON) and one post-injury (CARS). At baseline the larger CArBON study involves completion of a thorough single baseline neuroscientific assessment of healthy motorsport competitors including clinical, neuropsychological, neurocognitive, biomarker and vestibulo-ocular assessments, in addition to MRI of the brain. CArBON (baseline) fMRI The RESCUE-RACER programme is formed of two studies; baseline (CArBON) and one post-injury (CARS). At baseline the larger CArBON study involves completion of a thorough single baseline neuroscientific assessment of healthy motorsport competitors including clinical, neuropsychological, neurocognitive, biomarker and vestibulo-ocular assessments, in addition to MRI of the brain. CARS (exposure to a potentially concussive event) Saliva sample The RESCUE-RACER programme has a single post-injury study; after involvement in a potentially concussive event sustained during motorsport, CARS serially repeats the CArBON assessment battery in the immediate post-concussion recovery period. CARS participants will under-go post-exposure neuroscientific assessments immediately after injury and then at one, two and three weeks post-injury. If symptoms persist beyond this time, a further two assessments at monthly intervals will be offered. CArBON (baseline) Saliva sample The RESCUE-RACER programme is formed of two studies; baseline (CArBON) and one post-injury (CARS). At baseline the larger CArBON study involves completion of a thorough single baseline neuroscientific assessment of healthy motorsport competitors including clinical, neuropsychological, neurocognitive, biomarker and vestibulo-ocular assessments, in addition to MRI of the brain. CARS (exposure to a potentially concussive event) ImPACT The RESCUE-RACER programme has a single post-injury study; after involvement in a potentially concussive event sustained during motorsport, CARS serially repeats the CArBON assessment battery in the immediate post-concussion recovery period. CARS participants will under-go post-exposure neuroscientific assessments immediately after injury and then at one, two and three weeks post-injury. If symptoms persist beyond this time, a further two assessments at monthly intervals will be offered. CARS (exposure to a potentially concussive event) CANTAB The RESCUE-RACER programme has a single post-injury study; after involvement in a potentially concussive event sustained during motorsport, CARS serially repeats the CArBON assessment battery in the immediate post-concussion recovery period. CARS participants will under-go post-exposure neuroscientific assessments immediately after injury and then at one, two and three weeks post-injury. If symptoms persist beyond this time, a further two assessments at monthly intervals will be offered. CARS (exposure to a potentially concussive event) fMRI The RESCUE-RACER programme has a single post-injury study; after involvement in a potentially concussive event sustained during motorsport, CARS serially repeats the CArBON assessment battery in the immediate post-concussion recovery period. CARS participants will under-go post-exposure neuroscientific assessments immediately after injury and then at one, two and three weeks post-injury. If symptoms persist beyond this time, a further two assessments at monthly intervals will be offered. CArBON (baseline) CANTAB The RESCUE-RACER programme is formed of two studies; baseline (CArBON) and one post-injury (CARS). At baseline the larger CArBON study involves completion of a thorough single baseline neuroscientific assessment of healthy motorsport competitors including clinical, neuropsychological, neurocognitive, biomarker and vestibulo-ocular assessments, in addition to MRI of the brain. CArBON (baseline) I-PAS/Dx100 The RESCUE-RACER programme is formed of two studies; baseline (CArBON) and one post-injury (CARS). At baseline the larger CArBON study involves completion of a thorough single baseline neuroscientific assessment of healthy motorsport competitors including clinical, neuropsychological, neurocognitive, biomarker and vestibulo-ocular assessments, in addition to MRI of the brain. CARS (exposure to a potentially concussive event) Clinical assessment (SCAT5) The RESCUE-RACER programme has a single post-injury study; after involvement in a potentially concussive event sustained during motorsport, CARS serially repeats the CArBON assessment battery in the immediate post-concussion recovery period. CARS participants will under-go post-exposure neuroscientific assessments immediately after injury and then at one, two and three weeks post-injury. If symptoms persist beyond this time, a further two assessments at monthly intervals will be offered. CARS (exposure to a potentially concussive event) I-PAS/Dx100 The RESCUE-RACER programme has a single post-injury study; after involvement in a potentially concussive event sustained during motorsport, CARS serially repeats the CArBON assessment battery in the immediate post-concussion recovery period. CARS participants will under-go post-exposure neuroscientific assessments immediately after injury and then at one, two and three weeks post-injury. If symptoms persist beyond this time, a further two assessments at monthly intervals will be offered.
- Primary Outcome Measures
Name Time Method Change in computerised neuropsychological assessment scores Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments) 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:
1. Attention (processing and psychomotor speed)
2. Memory (visual episodic)
3. 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).Change in the brain's microstructural architecture, or functional changes in the brain Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments) Change in the brain's microstructural architecture, or functional changes in the brain, from baseline to follow-up as measured by:
1. High-resolution structural imaging - disruption of usual cerebral architecture (i.e. volume of sub/cortical structures)
2. Susceptibility-weighted imaging (SWI) - signal alteration
3. Diffusion-weighted imaging (DWI) - voxel intensity
4. Resting-state functional MRI (fMRI) - changes in blood oxygenation level
5. Proton spectroscopyChange in SCAT5 decision scores Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments) Change in performance on the Sports Concussion Assessment Tool 5 (SCAT5) from baseline to follow-up, as measured by sections of the assessment:
1. 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\*
2. Orientation score
3. Immediate memory score
4. Concentration score
5. Neurological examination
6. Number of balance errors
7. 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).Change in computerised neurocognitive assessment scores Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments) 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:
1. Attention (including processing)
2. Memory (verbal and visual recognition; visual working)
3. Visual motor speed
4. Learning
5. Impulse control (response inhibition)
6. 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).Change in salivary biomarker levels Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments) Change in the levels of salivary biomarkers from baseline to follow-up as potentially measured by markers of:
1. Neuronal injury - such as neurofilament light chain (NFL)
2. Glial injury - such as S100B (a calcium-binding peptide)
3. Epigenetic effects - as measured by micro RNA levels (miRNA)
4. Neurofibrillary degeneration - as measured by tau.
- Secondary Outcome Measures
Name Time Method Altered performance in ocular, vestibular and reaction time (OVRT) assessment utilising the I-PAS/Dx100 device Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments) 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:
1. Ocular tests - saccades (vertical, horizontal, predictive, self-paced, memory-guided and anti-), smooth pursuit, optokinetic reflex, vergence, light reflex
2. Vestibular tests - subjective visual vertical
3. 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).
Trial Locations
- Locations (1)
Mr Stephen Kelleher
🇬🇧Cambridge, Cambridgeshire, United Kingdom