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，但有关该问题的药物治疗的科学数据有限。由于已知工作记忆缺陷对脑外伤患者的功能结果有重大影响，因此该领域的进一步研究是必要的。该项目的主要目标是研究CDP胆碱治疗脑外伤后工作记忆缺陷的疗效。研究样本将由48名受试者组成，其中包括24名患有中度至重度脑外伤的个体和24名健康对照者。每一组将被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对大脑神经生理的影响。工作记忆任务将在fMRI期间进行。我们还将评估CDP胆碱治疗对神经心理测试成绩的影响，并观察行为表现与神经影像学结果之间的相关性。结果将在治疗前后或治疗后一个月进行比较。该研究假定了以下假设：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了改变；2)治疗后，TBI受试者的fMRI模式更接近健康对照；3)神经心理测试和工作记忆任务的行为表现的改善与治疗有关，在TBI组比较中变化更大；4)与安慰剂/对照组相比，TBI患者的神经心理测试和神经影像学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.