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

描述（由申请方提供）：尽管创伤性脑损伤（TBI）后工作记忆缺陷普遍存在，但关于该问题药物治疗的科学数据有限。由于工作记忆的缺陷已知对TBI患者的功能结果有显着影响，因此在这一领域的进一步研究至关重要。该项目的主要目的是研究CDP胆碱在治疗TBI后工作记忆缺陷中的疗效。研究样本将由48名受试者组成，包括一组24名持续中度至重度TBI的个体和一组24名健康对照。每组将分为安慰剂组和治疗组。该项目将利用功能性磁共振成像（fMRI）来研究所选药物治疗的脑神经生理学效应。工作记忆任务将在功能磁共振成像会议。还将评价CDP胆碱治疗对神经心理学测试表现的影响，并观察行为表现与神经影像学结果之间的相关性。结果将在测试前后或治疗后一个月进行比较。该研究假设了以下假设：1）基线fMRI结果将显示与正常人相比，TBI患者的大脑激活模式发生改变; 2）经过治疗，TBI受试者将显示更类似于健康对照组的fMRI模式; 3）神经心理学测试和工作记忆任务的行为表现改善将与治疗相关，TBI组比较的变化更大。4)与安慰剂/对照组相比，TBI患者的神经心理学测试和神经成像结果之间的相关性更强。

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.