CDP-Choline and Working Memory after Traumatic Brain Injury: A Neuroimaging Study

描述(由申请人提供)：尽管创伤性脑损伤(TBI)后普遍存在工作记忆缺陷，但关于这一问题的药物治疗的科学数据有限。众所周知，工作记忆缺陷会对脑外伤患者的功能结果产生重大影响，因此在这一领域进行进一步的研究是必要的。这项拟议项目的主要目标是检查CDP胆碱在治疗脑外伤后工作记忆障碍方面的疗效。研究样本将包括48名受试者，其中包括24名中重度脑外伤患者和24名健康对照。每组将分为安慰剂组和治疗组。该项目将利用功能磁共振成像(FMRI)来研究所选药物治疗的大脑神经生理效应。在功能磁共振成像过程中，将使用工作记忆任务。CDP胆碱治疗的效果也将在神经心理测试表现上进行评估，并将观察行为表现与神经影像结果之间的相关性。结果将在测试前后或治疗后一个月进行比较。这项研究假设以下假设：1)与正常人相比，脑损伤患者的基线功能磁共振成像结果将显示大脑激活模式的改变；2)经过治疗，脑损伤患者将显示出更类似于健康对照组的功能磁共振成像模式；3)神经心理测试和工作记忆任务的行为表现的改善将与治疗有关，脑损伤组的比较变化更大。4)与安慰剂/对照组相比，脑损伤患者的神经心理测试和神经成像结果之间的相关性将更强。

DESCRIPTION (provided by the applicant): Despite the prevalence of working memory deficits following traumatic brain injury (TBI), the scientific data regarding pharmacological treatment of this problem is limited. As deficits in working memory are known to have a significant impact on functional outcomes for individuals with TBI, further research in this area is essential. The primary goal of the proposed project is to examine the efficacy of CDP Choline in the treatment of working memory deficits following TBI. The study sample will consist of 48 subjects including a group of 24 individuals who have sustained moderate to severe TBI and a group of 24 healthy controls. Each group will be divided into a placebo and treatment group. The project will utilize functional Magnetic Resonance Imaging (fMRI) to investigate the cerebral neurophysiological effects of treatment with the drug of choice. A working memory task will be employed during the fMRI sessions. The effects of treatment with CDP Choline will be evaluated on neuropsychological testing performance also and correlations between behavioral performance and neuroimaging results will be observed. Results will be compared pre and post test or one month after treatment. The study postulates the following assumptions: 1) Baseline fMRI results will show altered patterns of cerebral activation for persons with TBI compared to normals; 2)With treatment, TBI subjects will display fMRI patterns that more resemble healthy controls; 3) Improvements in behavioral performance on both neuropsychological tests and the working memory task will be associated with treatment, with greater changes in the TBI group comparisons.; 4) correlations between neuropsychological tests and neuroimaging results will be stronger for persons with TBI as compared to placebo/control groups.