Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change in computerised neuropsychological assessment scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in computerised neuropsychological assessment scores
时间窗: 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
时间窗: 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 spectroscopy
Change in SCAT5 decision scores
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Naomi D Deakin
Study Coordinator
University of Cambridge