Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 16 years and older
• All sexes
• Healthy volunteers accepted
• Child, Adult, Older adult

Study population: Eligibility Criteria-CArBON; all competitors associated with the TOCA* series or contracted by Aston Martin Racing (AMR) Eligibility Criteria-CARS; following exposure to a potentially concussive event sustained during motorsport activity: a) All competitors associated with the TOCA series or contracted by AMR b) Any competitive motorsports competitors who are referred to the Chief Investigator *'TOCA' is a motorsports event package based in the UK (registered as a Patient Identification Centre, PIC). In 2019, TOCA consists of 6 semi-/professional racing series (3 adult-British Touring Car Championship (BTCC), Porsche Carrera Cup GB, Michelin Ginetta GT4 Supercup; 1 mixed age-Renault UK Clio Cup (17 years+); 2 adolescent (14-17 years)-Simpson Race Products Ginetta Junior Championships, British Formula 4 Championship; certified by Fédération Internationale de l'Automobile, FIA; powered by Ford).In 2020, Renault is replaced by the Mini Challenge series.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Concussion, Brain, Motor Vehicle Accident

Being tested

Clinical assessment (SCAT5), ImPACT, CANTAB, I-PAS/Dx100, Saliva sample

Keywords

Concussion, mTBI, mild traumatic brain injury, motorsport, motor sport, racing

Medical subject headings

Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Clinical assessment (SCAT5)Diagnostic test

  Also called Sports Concussion Assessment Tool 5

  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.

• ImPACTDiagnostic test

  Also called Immediate Post-concussion Assessment and Cognitive Testing, ImPACT concussion test

  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.

• CANTABBehavioural

  Also called CANTAB Connect, Cambridge Cognition CANTAB battery, CANTAB battery

  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.

• I-PAS/Dx100Diagnostic test

  Also called OVRT, Ocular, vestibular and reaction time testing, I-Portal Portable Assessment System, Video Oculography

  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.

• Saliva sampleBiological

  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.

• fMRIOther

  Also called Magnetic Resonance Imaging, Function MRI

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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:

   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).

   Measured: Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)

2. 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:

   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).

   Measured: Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)

3. 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:

   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).

   Measured: Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)

4. 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:

   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 spectroscopy

   Measured: Baseline (CArBON assessment) to 1-3 weeks after concussion (CARS assessments)

5. Change in salivary biomarker levels

   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.

   Measured: Baseline (CArBON assessments) to 1-3 weeks after concussion (CARS assessments)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Feb 2019
2. Study start9 Nov 2018
3. Primary completion31 Dec 2020
4. Study completion31 Dec 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Concussion, BrainStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.