Dymowski Alicia R, Ponsford Jennie L, Owens Jacqueline A, Olver John H, Ponsford Michael, Willmott Catherine
1 School of Psychological Sciences and Monash Institute of Cognitive and Clinical Neurosciences, Monash University, Australia.
2 Monash-Epworth Rehabilitation Research Centre, Epworth HealthCare, Australia.
Clin Rehabil. 2017 Jun;31(6):733-741. doi: 10.1177/0269215516655590. Epub 2016 Jun 27.
To investigate the feasibility, safety and efficacy of extended-release methylphenidate in enhancing processing speed, complex attentional functioning and everyday attentional behaviour after traumatic brain injury.
Seven week randomised, placebo-controlled, double-blind, parallel pilot study.
Inpatient and outpatient Acquired Brain Injury Rehabilitation Program.
Eleven individuals with reduced processing speed and/or attention deficits following complicated mild to severe traumatic brain injury.
Participants were allocated using a blocked randomisation schedule to receive daily extended-release methylphenidate (Ritalin LA at a dose of 0.6 mg/kg) or placebo (lactose) in identical capsules.
Tests of processing speed and complex attention, and ratings of everyday attentional behaviour were completed at baseline, week 7 (on-drug), week 8 (off-drug) and 9 months follow-up. Vital signs and side effects were monitored from baseline to week 8.
Three percent ( n = 11) of individuals screened participated (mean post-traumatic amnesia duration = 63.80 days, SD = 45.15). Results were analysed for six and four individuals on methylphenidate and placebo, respectively. Groups did not differ on attentional test performance or relative/therapist ratings of everyday attentional behaviour. One methylphenidate participant withdrew due to difficulty sleeping. Methylphenidate was associated with trends towards increased blood pressure and reported anxiety.
Methylphenidate was not associated with enhanced processing speed, attentional functioning or everyday attentional behaviour after traumatic brain injury. Alternative treatments for attention deficits after traumatic brain injury should be explored given the limited feasibility of methylphenidate in this population.
探讨缓释哌醋甲酯在提高创伤性脑损伤后处理速度、复杂注意力功能及日常注意力行为方面的可行性、安全性和有效性。
为期7周的随机、安慰剂对照、双盲、平行先导研究。
住院和门诊获得性脑损伤康复项目。
11名在复杂的轻度至重度创伤性脑损伤后处理速度降低和/或存在注意力缺陷的个体。
采用分组随机化方案分配参与者，使其每日服用相同胶囊装的缓释哌醋甲酯（利他林长效片，剂量为0.6mg/kg）或安慰剂（乳糖）。
在基线、第7周（服药时）、第8周（停药时）和9个月随访时完成处理速度和复杂注意力测试，以及日常注意力行为评分。从基线到第8周监测生命体征和副作用。
筛选的个体中有3%（n = 11）参与研究（创伤后遗忘症平均持续时间 = 63.80天，标准差 = 45.15）。分别对6名服用哌醋甲酯和4名服用安慰剂的个体的结果进行了分析。两组在注意力测试表现或日常注意力行为的相对/治疗师评分上没有差异。一名服用哌醋甲酯的参与者因睡眠困难退出。哌醋甲酯与血压升高趋势和报告的焦虑有关。
创伤性脑损伤后，哌醋甲酯与处理速度、注意力功能或日常注意力行为的改善无关。鉴于哌醋甲酯在该人群中的可行性有限，应探索创伤性脑损伤后注意力缺陷的替代治疗方法。
