Hamzah Norhamizan, Narayanan Vairavan, Ramli Norlisah, Mustapha Nor Atikah, Mohammad Tahir Nor Adibah, Tan Li Kuo, Danaee Mahmoud, Muhamad Nor Asiah, Drummond Avril, das Nair Roshan, Goh Sing Yau, Mazlan Mazlina
Department of Rehabilitation Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
BMJ Open. 2019 Sep 18;9(9):e028711. doi: 10.1136/bmjopen-2018-028711.
To measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population.
A single centre study, Malaysia.
Adults aged between 18 and 60 years with mTBI as a result of road traffic accident, with no previous history of head trauma, minimum of 9 years education and abnormal cognition at 3 months will be included. The exclusion criteria include pre-existing chronic illness or neurological/psychiatric condition, long-term medication that affects cognitive/psychological status, clinical evidence of substance intoxication at the time of injury and major polytrauma. Based on multiple estimated calculations, the minimum intended sample size is 50 participants (Cohen's d effect size=0.35; alpha level of 0.05; 85% power to detect statistical significance; 40% attrition rate).
Intervention group will receive individualised structured cognitive rehabilitation. Control group will receive the best patient-centred care for attention disorders. Therapy frequency for both groups will be 1 hour per week for 12 weeks.
Neuropsychological Assessment Battery-Screening Module (S-NAB) scores. Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS).
Results will include descriptive statistics of population demographics, CogniPlus cognitive program and metacognitive strategies. The effect of intervention will be the effect size of S-NAB scores and mean GAS T scores. DTI parameters will be compared between groups via repeated measure analysis. Correlation analysis of outcome measures will be calculated using Pearson's correlation coefficient.
This is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model.
The study protocol was approved by the Medical Research Ethics Committee UMMC (MREC ID NO: 2016928-4293). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
NCT03237676.
测量个体化结构化认知康复对轻度创伤性脑损伤（mTBI）人群的临床、结构和功能变化。
马来西亚的一项单中心研究。
年龄在18至60岁之间，因道路交通事故导致mTBI，既往无头部外伤史，至少接受9年教育且在3个月时认知异常的成年人将被纳入。排除标准包括既往存在的慢性疾病或神经/精神疾病、影响认知/心理状态的长期药物治疗、受伤时物质中毒的临床证据以及严重多发伤。基于多次估计计算，最小预期样本量为50名参与者（科恩d效应量=0.35；α水平为0.05；检测统计学显著性的功效为85%；损耗率为40%）。
干预组将接受个体化结构化认知康复。对照组将接受针对注意力障碍的最佳以患者为中心的护理。两组的治疗频率均为每周1小时，共12周。
神经心理评估量表筛查模块（S-NAB）评分、扩散张量成像（DTI）参数和目标达成量表评分（GAS）。
结果将包括人群人口统计学、CogniPlus认知计划和元认知策略的描述性统计。干预效果将以S-NAB评分和平均GAS T评分的效应量表示。将通过重复测量分析比较两组之间的DTI参数。将使用Pearson相关系数计算结局指标的相关分析。
这是一项具有多个结局指标的复杂临床干预，旨在提供一个全面的循证治疗模型。
该研究方案已获得马来西亚马来亚大学医学中心医学研究伦理委员会的批准（MREC ID NO: 2016928 - 4293）。该试验的结果将通过同行评审期刊和科学会议进行传播。
NCT03237676。
