Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03844282
Other study ID # A094577
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 9, 2018
Est. completion date December 31, 2022

Study information

Verified date December 2023
Source University of Cambridge
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date December 31, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United Kingdom Mr Stephen Kelleher Cambridge Cambridgeshire

Sponsors (5)

Lead Sponsor Collaborator
University of Cambridge Cambridge University Hospitals NHS (National Health Service) Foundation Trust, Federation Internationale de l'Automobile - Year 2 onwards, Global Institute for Motorsport Safety (GIMSS) - Year 1, Neurolign Technologies LLC (previously Neuro Kinetics Incorporated, NKI)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in SCAT5 decision scores Change in performance on the Sports Concussion Assessment Tool 5 (SCAT5) from baseline to follow-up, as measured by sections of the assessment:
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*
Orientation score
Immediate memory score
Concentration score
Neurological examination
Number of balance errors
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).
Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
Primary Change in computerised neurocognitive assessment scores 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:
Attention (including processing)
Memory (verbal and visual recognition; visual working)
Visual motor speed
Learning
Impulse control (response inhibition)
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).
Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
Primary Change in computerised neuropsychological assessment scores 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:
Attention (processing and psychomotor speed)
Memory (visual episodic)
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).
Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
Primary Change in the brain's microstructural architecture, or functional changes in the brain Change in the brain's microstructural architecture, or functional changes in the brain, from baseline to follow-up as measured by:
High-resolution structural imaging - disruption of usual cerebral architecture (i.e. volume of sub/cortical structures)
Susceptibility-weighted imaging (SWI) - signal alteration
Diffusion-weighted imaging (DWI) - voxel intensity
Resting-state functional MRI (fMRI) - changes in blood oxygenation level
Proton spectroscopy
Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)
Primary Change in salivary biomarker levels Change in the levels of salivary biomarkers from baseline to follow-up as potentially measured by markers of:
Neuronal injury - such as neurofilament light chain (NFL)
Glial injury - such as S100B (a calcium-binding peptide)
Epigenetic effects - as measured by micro RNA levels (miRNA)
Neurofibrillary degeneration - as measured by tau.
Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
Secondary Altered performance in ocular, vestibular and reaction time (OVRT) assessment utilising the I-PAS/Dx100 device 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:
Ocular tests - saccades (vertical, horizontal, predictive, self-paced, memory-guided and anti-), smooth pursuit, optokinetic reflex, vergence, light reflex
Vestibular tests - subjective visual vertical
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).
Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04109677 - AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball
Recruiting NCT04932278 - The Role of Osteopathic Manipulative Medicine in Recovery From Concussions N/A
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Recruiting NCT05682677 - Combined Neuromodulation and Cognitive Training for Post-mTBI Depression N/A
Recruiting NCT04992130 - Sport Concussion Performance-Based Prevention Program N/A
Completed NCT05095012 - RECOVER Clinical Pathway for Pediatric Concussion N/A
Recruiting NCT05886400 - The Effects of Environmental Distractions on SCAT6 Outcomes N/A
Active, not recruiting NCT05400551 - Craneofacial Injuries in Rink Hockey Athletes
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Withdrawn NCT03575741 - Postural Control in Children and Adolescents After Suffering From a Concussion
Active, not recruiting NCT05471791 - Development of a Concussion Management Platform for Children and Youth N/A
Completed NCT04730167 - The Monaco Initiative for Concussion in Motorsport Pilots
Completed NCT03478059 - Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI N/A
Recruiting NCT05685121 - A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents N/A
Completed NCT04122274 - Comparing and Interactive Concussion Education Platform to Current Education Standards N/A
Completed NCT04558346 - Ghrelin (OXE--103) for Acute Concussion Management Phase 2
Completed NCT04074486 - Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
Not yet recruiting NCT05562232 - The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms N/A
Recruiting NCT05326555 - Dynamic Vision Testing and Concussion Management Dream Team 65
Completed NCT03671083 - Validation of Brain Function Assessment Algorithm for mTBI/Concussion