Clinical Research in Epilepsy and Associated Disorders

描述(由申请人提供)：以患者为导向的结果调查对于推进慢性神经疾病(如癫痫)的临床研究和护理至关重要，这些疾病具有复杂的认知、情绪、社会、职业和致病因素的相互作用。我们打算利用一项前瞻性随机试验(R01 NS40808)，比较选择性5-羟色胺再摄取抑制剂和认知行为疗法对患有癫痫和抑郁症的患者的情绪、用药依从性、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方面的培训。即将进行的资助研究将应用创新策略来推进以患者为中心的神经科学，例如18FDG-PET与结构磁共振共同注册，以绘制代谢变异性的区域参数统计图，并研究特定大脑区域的功能障碍与抑郁症状严重程度的关系。我们将每周举办一次以患者为中心的研究研讨会，就生物统计学的应用、研究设计和解释以及临床研究中的后勤策略提供指导。该研讨会还将被用来促进开发、实施和分析受训人员进行的研究项目。参与者将包括获得临床K系列奖的初级教员、癫痫研究员、我们NIH部门支持的培训奖助金获得者(四人/年)和以学业为导向的住院医生。这一计划应该允许通过对初级研究人员的纵向强化培训和指导，提高未来神经科学中以患者为导向的研究的质量和数量。

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.