RCT Methylphenidate & Memory/Attention Training in Traumatic Brain Injury

随机对照试验哌甲酯

• 批准号: 7028739
• 负责人: Thomas McAllister
• 金额: $ 38.93万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7028739
• 关键词: attention; behavioral /social science research tag; brain disorder chemotherapy; brain electrical activity; brain injury; cingulate gyrus; clinical research; clinical trials; cognition disorders; cognitive behavior therapy; combination therapy; functional magnetic resonance imaging; human subject; human therapy evaluation; memory; methylphenidate; patient oriented research; prefrontal lobe /cortex; trauma

DESCRIPTION (provided by applicant): Traumatic brain injury (TBI) is a significant public health problem, with 1.5-2.0 million Americans injured each year. Cognitive deficits, particularly in the domains of memory and attention are frequently the source of lingering disability after TBI and a source of enormous distress to the injured individuals and their family/caregivers. To date, interventions to ameliorate chronic cognitive deficits have been directed at either pharmacological interventions or cognitive rehabilitation. We propose to (1) To compare the efficacy of three interventions: memory and attention training (MAAT), methylphenidate, and memory/attention training in combination with methylphenidate and (2) use functional MRI (fMRI) to characterize changes in activation of the neural circuitry of memory and attention due to MAAT alone, methylphenidate alone, and MAAT in combination with methylphenidate. This is a two by two design with medication (methylphenidate/placebo) and cognitive therapy (Memory and Attention Training (MAAT) or an Attention control intervention) as possible interventions. Using a randomized, placebo-controlled, double-blind design, 200 individuals with persistent cognitive deficits 6-12 months after MTBI will be randomized to receive a six week trial of either (1) MAAT and placebo, (2) MAAT and methylphenidate (0.3 mg/kg BID) (3) attention control intervention and methylphenidate (0.3 mg/kg BID) or (4) attention control intervention and placebo. Symptom distress attention and memory performance, and activation patterns of the neural circuitry of attention and memory while undergoing fMRI will be characterized at baseline, and after the four treatment conditions. This study will provide important information on three interventions for the most disabling sequelae of an enormous public health problem. Further, it will help to clarify underlying neural mechanisms and suggest additional treatment possibilities.

描述（由申请人提供）：创伤性脑损伤（TBI）是一个重大的公共卫生问题，每年有150万至200万美国人受伤。 认知缺陷，特别是在记忆和注意力领域的认知缺陷通常是TBI后持续残疾的来源，也是受伤者及其家人/照顾者巨大痛苦的来源。 迄今为止，改善慢性认知缺陷的干预措施已经针对药物干预或认知康复。 我们建议：（1）比较三种干预措施的疗效：记忆和注意力训练（MAAT），哌甲酯，记忆/注意力训练与哌甲酯的组合;（2）使用功能性MRI（fMRI）来表征由于MAAT单独，哌甲酯单独和MAAT与哌甲酯组合引起的记忆和注意力神经回路激活的变化。 这是一种二乘二设计，药物（哌醋甲酯/安慰剂）和认知治疗（记忆和注意力训练（MAAT）或注意力控制干预）作为可能的干预措施。 使用随机化、安慰剂对照、双盲设计，MTBI后6-12个月具有持续认知缺陷的200个个体将被随机化以接受（1）MAAT和安慰剂、（2）MAAT和哌醋甲酯（0.3mg/kg BID）、（3）注意力控制干预和哌醋甲酯（0.3mg/kg BID）或（4）注意力控制干预和安慰剂的六周试验。 将在基线和四种治疗条件后表征症状困扰注意力和记忆力表现，以及进行fMRI时注意力和记忆神经回路的激活模式。 这项研究将提供关于三种干预措施的重要信息，用于解决一个巨大的公共卫生问题的最致残后遗症。 此外，它将有助于澄清潜在的神经机制，并提出其他治疗的可能性。