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 15-200 万美国人受伤。 认知缺陷，尤其是记忆和注意力领域的认知缺陷，常常是创伤性脑损伤后挥之不去的残疾的根源，也是受伤者及其家人/护理人员巨大痛苦的根源。 迄今为止，改善慢性认知缺陷的干预措施主要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效果：记忆和注意力训练 (MAAT)、哌醋甲酯以及记忆/注意力训练与哌醋甲酯联合使用；(2) 使用功能性 MRI (fMRI) 来表征神经元激活的变化。单独使用 MAAT、单独使用哌醋甲酯以及 MAAT 与哌甲酯联用导致的记忆和注意力神经回路。 这是一个二对二的设计，以药物（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。 采用随机、安慰剂对照、双盲设计，200 名在 MTBI 后 6-12 个月有持续性认知缺陷的个体将被随机分配接受为期六周的试验，试验组包括 (1) MAAT 和安慰剂，(2) MAAT 和哌甲酯（ 0.3 mg/kg BID）（3）注意力控制干预和哌醋甲酯（0.3 mg/kg BID）或（4）注意力控制干预和安慰剂。 进行功能磁共振成像时，注意力和记忆表现不佳的症状以及注意力和记忆神经回路的激活模式将在基线时和四种治疗条件后进行表征。 这项研究将为针对巨大公共卫生问题最严重的后遗症提供三种干预措施的重要信息。 此外，它将有助于阐明潜在的神经机制并提出额外的治疗可能性。