RESUMEN
The brain is the control centre of the human body. Injury to the brain can have diverse and disabling effects. Yet there remain important unanswered questions for clinicians, those affected and their families. This special collection aims to advance understanding of how we can better diagnose, treat and support those affected by brain injury across the severity spectrum.
Asunto(s)
Lesiones Traumáticas del Encéfalo , Lesiones Encefálicas , Humanos , Lesiones Traumáticas del Encéfalo/terapia , Lesiones Encefálicas/terapia , Lesiones Encefálicas/diagnóstico , EncéfaloRESUMEN
BACKGROUND AND PURPOSE: Treatments to facilitate recovery after traumatic brain injury (TBI) are urgently needed. We conducted a 9-month pilot, randomized placebo-controlled clinical trial to examine the safety and potential effects of the herbal supplement MLC901 (NeuroAiD II™) on cognitive functioning following TBI. METHODS: Adults aged 18-65 years at 1-12 months after mild or moderate TBI were randomized to receive MLC901 (0.8 g capsules 3 times daily) or placebo for 6 months. The primary outcome was cognitive functioning as assessed by the CNS Vital Signs online neuropsychological test. Secondary outcomes included the Cognitive Failures Questionnaire, the Rivermead Post-concussion Symptom Questionnaire (neurobehavioral sequelae), Quality of Life after Brain Injury, Hospital Anxiety and Depression Scale, Modified Fatigue Impact Scale and extended Glasgow Outcome Scale (physical disability). Assessments were completed at baseline and at 3-, 6- and 9-month follow-up. Linear mixed-effects models were conducted, with the primary outcome time-point of 6 months. RESULTS: A total of 78 participants [mean age 37.5 ± 14.8 years, 39 (50%) female] were included in the analysis. Baseline variables were similar between groups (treatment group, n = 36; control group, n = 42). Linear mixed-effects models controlling for time, group allocation, repeated measurements, adherence and baseline assessment scores revealed significant improvements in complex attention (P = 0.04, d = 0.6) and executive functioning (P = 0.04, d = 0.4) at 6 months in the MLC901 group compared with controls. There were no significant differences between the groups for neurobehavioral sequelae, mood, fatigue, physical disability or overall quality of life at 6 months. No serious adverse events were reported. CONCLUSIONS: MLC901 was safe and well tolerated post-TBI. This study provided Class I/II evidence that, for patients with mild to moderate TBI, 6 months of MLC901 improved cognitive functioning.
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Lesiones Traumáticas del Encéfalo/tratamiento farmacológico , Lesiones Traumáticas del Encéfalo/psicología , Cognición , Medicamentos Herbarios Chinos/uso terapéutico , Fármacos Neuroprotectores/uso terapéutico , Adolescente , Adulto , Anciano , Trastornos del Conocimiento/etiología , Trastornos del Conocimiento/prevención & control , Evaluación de la Discapacidad , Método Doble Ciego , Función Ejecutiva , Femenino , Escala de Consecuencias de Glasgow , Humanos , Masculino , Persona de Mediana Edad , Pruebas Neuropsicológicas , Proyectos Piloto , Calidad de Vida , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: Depression is common post-TBI, yet has not been studied longitudinally, nor at a population level. This study examined prevalence of depression in a population-based sample across the first year post-TBI. DESIGN AND METHODS: Prospective follow-up of 315 adults (>16 years) with assessments (Hospital Anxiety Depression Scale, DSM-IV criteria) at 1-, 6- and 12-months post-TBI. Demographic and injury-related predictors of depression at 1-year post-TBI were also explored. RESULTS: The number of individuals identified as depressed reduced significantly between baseline and 12-months post-TBI from 21-12.4% using the HADS and 49-34% using DSM-IV criteria; with only 10 of the 28 individuals initially meeting criteria on the HADS continuing to do so at 12-month follow-up. Meeting HADS depression criteria was linked to pre-morbid depression and/or anxiety; while those meeting DSM-IV criteria were older, but not significantly so. CONCLUSIONS: The findings suggest depression is common post-TBI and that clinicians/researchers use caution in its diagnosis, as existing criteria have significant overlap with common TBI sequels.
Asunto(s)
Ansiedad/diagnóstico , Lesiones Encefálicas/psicología , Depresión/diagnóstico , Personas con Discapacidad/psicología , Adulto , Factores de Edad , Ansiedad/etiología , Lesiones Encefálicas/complicaciones , Lesiones Encefálicas/fisiopatología , Estudios Transversales , Depresión/etiología , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Personas con Discapacidad/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Pruebas Neuropsicológicas , Nueva Zelanda/epidemiología , Valor Predictivo de las Pruebas , Prevalencia , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND AND PURPOSE: Enzogenol, a flavonoid-rich extract from Pinus radiata bark with antioxidant and anti-inflammatory properties has been shown to improve working memory in healthy adults. In traumatic brain injury (TBI), oxidation and inflammation have been linked to poorer cognitive outcomes. Hence, this phase II, randomized controlled trial investigated safety, compliance and efficacy of Enzogenol for improving cognitive functioning in people following mild TBI. METHODS: Sixty adults, who sustained a mild TBI, 3-12 months prior to recruitment, and who were experiencing persistent cognitive difficulties [Cognitive Failures Questionnaire (CFQ) score > 38], were randomized to receive Enzogenol (1000 mg/day) or matching placebo for 6 weeks. Subsequently, all participants received Enzogenol for a further 6 weeks, followed by placebo for 4 weeks. Compliance, side-effects, cognitive failures, working and episodic memory, post-concussive symptoms and mood were assessed at baseline, 6, 12 and 16 weeks. Simultaneous estimation of treatment effect and breakpoint was effected, with confidence intervals (CIs) obtained through a treatment-placebo balance-preserving bootstrap procedure. RESULTS: Enzogenol was found to be safe and well tolerated. Trend and breakpoint analyses showed a significant reduction in cognitive failures after 6 weeks [mean CFQ score, 95% CI, Enzogenol versus placebo -6.9 (-10.8 to -4.1)]. Improvements in the frequency of self-reported cognitive failures were estimated to continue until week 11 before stabilizing. Other outcome measures showed some positive trends but no significant treatment effects. CONCLUSIONS: Enzogenol supplementation is safe and well tolerated in people after mild TBI, and may improve cognitive functioning in this patient population. This study provides Class IIB evidence that Enzogenol is well tolerated and may reduce self-perceived cognitive failures in patients 3-12 months post-mild TBI.
Asunto(s)
Lesiones Encefálicas/complicaciones , Trastornos del Conocimiento/tratamiento farmacológico , Trastornos del Conocimiento/etiología , Suplementos Dietéticos , Flavonoides/uso terapéutico , Quercetina/análogos & derivados , Accidentes de Tránsito , Adulto , Lesiones Encefálicas/psicología , Trastornos del Conocimiento/psicología , Interpretación Estadística de Datos , Método Doble Ciego , Femenino , Flavonoides/efectos adversos , Escala de Coma de Glasgow , Humanos , Masculino , Memoria/fisiología , Persona de Mediana Edad , Pruebas Neuropsicológicas , Dinámicas no Lineales , Cooperación del Paciente , Proyectos Piloto , Síndrome Posconmocional/tratamiento farmacológico , Síndrome Posconmocional/psicología , Quercetina/efectos adversos , Quercetina/uso terapéutico , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: Drawing on the experience of conducting the Brain Injury Incidence and Outcomes New Zealand in the Community study, this article aims to identify the issues arising from the implementation of proposed guidelines for population-based studies of incidence and outcomes in traumatic brain injury (TBI). STUDY DESIGN AND SETTING: All new cases of TBI (all ages and severities) were ascertained over a 1-year period, using overlapping prospective and retrospective sources of case ascertainment in New Zealand. All eligible TBI cases were invited to participate in a comprehensive assessment at baseline and at 1-month follow-up. RESULTS: Our experience to date has revealed the feasibility of case ascertainment methods. Consultation with community health services and professionals resulted in feasible referral pathways to support the identification of TBI cases. 'Hot pursuit' methods of recruitment were essential to ensure complete case ascertainment for this population with few additional cases of TBI identified through cross-checks. CONCLUSION: This review of proposed guidelines in relation to practical study methodology provides a framework for future comparable population-based epidemiological studies of TBI incidence and outcomes in developed countries.