Clinical Research in Epilepsy and Associated Disorders

描述（由申请人提供）：以患者为导向的结局研究对于推进慢性神经系统疾病（如癫痫）的临床研究和护理至关重要，这些疾病具有认知、情感、社会、职业和致创伤因素的复杂相互作用。我们打算利用一项前瞻性随机试验（R 01 NS 40808），比较选择性5-羟色胺再摄取抑制剂和认知行为治疗对癫痫和抑郁共病患者的情绪、药物依从性、癫痫发作和健康结局的影响，以支持对初级研究人员进行临床研究方法培训。即将资助的研究将采用创新策略来推进以患者为导向的神经科学，例如18FDG-PET与结构MRI的共配准，用于代谢变异性和抑郁症量表评分的区域参数统计映射，以研究特定大脑区域功能障碍与抑郁症症状严重程度的关联。我们将实施每周一次的以患者为导向的研究研讨会，为临床研究中生物统计学，研究设计和解释以及后勤策略的应用提供指导。该研讨会还将用于促进受训人员开展的研究项目的制定、实施和分析。参与者将包括初级教师与临床K系列奖，癫痫研究员，我们的部门NIH支持的培训补助金获奖者（四/年），和学术导向的居民。该计划应允许通过纵向强化培训和指导初级研究人员在未来的神经科学以患者为导向的研究的质量和数量的改善。

DESCRIPTION (provided by applicant): Patient-oriented outcomes investigation is essential for the advancement of clinical research and care of chronic neurological conditions such as epilepsy, which have complex interactions of cognitive, emotional, social, vocational and iatragenic factors. We intend to utilize a prospective randomized trial (R01 NS40808) that compares the effects of a selective serotonin re-uptake inhibitor and cognitive behavior therapy on mood, medication compliance, seizures, and health outcomes in persons with co-morbid epilepsy and depression to support training of junior investigators in clinical research methods. Upcoming funded research studies will apply innovative strategies to advance patient-oriented neuroscience, such as 18FDG-PET co-registration with structural MRI for regional parametric statistical mapping of metabolic variability and Depression Inventory Scores to study the association of dysfunction in specific brain regions with severity of symptoms of depression. We will implement a weekly Seminar in Patient-Oriented Research to provide mentoring on the application of biostatistics, study design and interpretation, and logistical strategies in clinical research. This seminar will also be used to facilitate the development, implementation, and analysis of research projects performed by trainees. Participants will include junior faculty with clinical K-series Awards, epilepsy fellows, our departmental NIH-supported training grant awardees (four/year), and academically oriented residents. This program should allow improvement in the quality and quantity of future patient-oriented research in neuroscience through longitudinal intensive training and mentoring of junior investigators.