Tramontana Michael G, Cowan Ronald L, Zald David, Prokop Jonathan W, Guillamondegui Oscar
Department of Psychiatry .
Brain Inj. 2014;28(11):1461-72. doi: 10.3109/02699052.2014.930179. Epub 2014 Jul 2.
Attention deficits are often among the most persistent and debilitating impairments resulting from traumatic brain injury (TBI). This study examined the effects of lisdexamfetamine dimesylate (Vyvanse) in treating attention deficits due to moderate-to-severe TBI. It was the first study of lisdexamfetamine dimesylate with this population and, in fact, was the first controlled trial in this area examining a stimulant medication option other than methylphenidate.
This was a 12-week, randomized, double-blind, placebo-controlled, cross-over trial. A total of 22 rigorously selected cases were enrolled, 13 of whom completed the trial. They were 16-42 years of age and had newly acquired attention deficits persisting for 6-34 months post-injury. They were assessed on a broad range of neuropsychological and behavioural measures at baseline, 6-weeks and at 12-weeks.
Positive treatment effects were found involving selective measures of sustained attention, working memory, response speed stability and endurance and in aspects of executive functioning. No major problems with safety or tolerability were observed. Some moderating treatment effects were found from a broad range of pre-treatment subject characteristics and injury variables examined. Avenues for further research and treatment applications in this area are discussed.
注意力缺陷常常是创伤性脑损伤(TBI)所致最持久且使人衰弱的损伤之一。本研究考察了二甲磺酸赖右苯丙胺(维万思)治疗中重度TBI所致注意力缺陷的效果。这是第一项针对该人群使用二甲磺酸赖右苯丙胺的研究,实际上也是该领域第一项检验除哌甲酯之外的刺激性药物选择的对照试验。
这是一项为期12周的随机、双盲、安慰剂对照、交叉试验。共纳入22例经过严格筛选的病例,其中13例完成试验。他们年龄在16至42岁之间,受伤后新出现持续6至34个月的注意力缺陷。在基线、6周和12周时对他们进行了广泛的神经心理学和行为测量评估。
发现了积极的治疗效果,涉及持续注意力、工作记忆、反应速度稳定性和耐力的选择性测量以及执行功能方面。未观察到安全性或耐受性方面的重大问题。从所考察的广泛的治疗前受试者特征和损伤变量中发现了一些调节性治疗效果。讨论了该领域进一步研究和治疗应用的途径。