UMN Udall Clinical Core

UMN Udall 临床核心

基本信息

批准号：
10282961
负责人：
SCOTT E COOPER
金额：
$ 42.4万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-17 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10282961
关键词：
Adverse event Behavioral Biological Markers Biometry Biostatistics Core Clinical Clinical Data Clinical assessments Collaborations Common Data Element Consent Data Data Element Data Management Resources Data Set Deep Brain Stimulation Devices Doctor of Philosophy Dopa Electrophysiology (science)Enrollment Ensure Future Goals Home Image Manufacturer Name Microelectrodes Minnesota Monitor Motor Movement Disorders National Institute of Neurological Disorders and Stroke Neurologic Neuropsychology Operating Rooms Operative Surgical Procedures Outcome Parkinson Disease Participant Patient Education Patients Physiological Postoperative Period Protocols documentation Research Resistance Schedule Standardization Sulfur Symptoms Time Universities Work base catalyst clinical center clinically significant cohort experience follow-up human subject programs recruit repository sensor technology smartphone Application success wearable device

项目摘要

The University of Minnesota (UMN) Udall Center Clinical Core will be led by Scott Cooper PhD, MD and Paul Tuite, MD. The Clinical Core will recruit 100 patients with Parkinson's disease (PD) who are candidates for deep brain stimulation (DBS) for the human subjects protocols associated with Projects 1 and 2 and the Catalyst Project. The Clinical Core will collect pre-surgical baseline and longitudinal motor and non-motor assessments using NINDS PD-specific Common Data Elements (CDE) as well as DBS programming data. The Clinical Core will also collect baseline biosamples from enrolled participants for the BioSEND repository to supplement the CDE’s that Biostatistics Core will enter into the NINDS Parkinson’s Disease Biomarkers Program Data Management Resource. In collaboration with the University of Rochester Udall Center and Sage Biometrics, the UMN Clinical Core will collect in-home assessments using the mPower 2.0 smartphone app for Project 2, extending this app to a new cohort of PD patients with DBS. The Clinical Core will work closely with the Biostatistics, Administrative, and Imaging Core to support all Center and Project aims.

明尼苏达大学（UMN）UDALL中心临床核心将由斯科特·库珀（Scott Cooper）博士和保罗（Paul）领导马里兰州卢特。临床核心将招募100名帕金森氏病（PD）患者，他们是候选人与项目1和2相关的人类受试者方案的深度大脑刺激（DB）和催化剂项目。临床核心将收集手术前的基线和纵向运动和非运动器使用NINDS PD特异性通用数据元素（CDE）以及DBS编程数据进行评估。临床核心还将从注册参与者的生物端存储库中收集基线生物样本到补充CDE，即生物统计学核心将进入Ninds Parkinson Disision生物标志物程序数据管理资源。与罗切斯特大学Udall Center和Sage合作生物识别技术，UMN临床核心将使用MPower 2.0智能手机应用程序收集家庭评估项目2，将此应用程序扩展到新的DBS PD患者组。临床核心将与生物统计学，行政和成像核心，以支持所有中心和项目的目标。