SETTING: A single centre study, Malaysia.
PARTICIPANTS: 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).
INTERVENTIONS: 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.
OUTCOME MEASURES: Primary: Neuropsychological Assessment Battery-Screening Module (S-NAB) scores. Secondary: Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS).
RESULTS: 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.
CONCLUSION: This is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: NCT03237676.
METHODS: Sixty-one patients with mTBI (Glasgow Coma Scale score 13-15) were recruited prospectively, categorized according to baseline computed tomography findings, and subjected to neuropsychological assessment at initial admission (n = 61) as well as at a 6-month follow-up (n = 30). The paired t test, Cohen's d effect size calculation, and repeated-measures analysis of variance were used to establish the differences between the 2 groups in terms of neuropsychological performance.
RESULTS: A trend toward poorer neuropsychological performance among the patients with complicated mTBI was observed during admission; however, performance in this group improved over time. In contrast, the uncomplicated mTBI group showed slower recovery, especially in tasks of memory, visuospatial processing, and executive functions, at follow-up.
CONCLUSIONS: Our findings suggest that despite the broad umbrella designation of mTBI, the current classification schemes of injury severity for mild neurotrauma should be revisited. They also raise questions about the clinical relevance of both traumatic focal lesions and the absence of visible traumatic lesions on brain imaging studies in patients with milder forms of head trauma.