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) 尤德尔中心临床核心将由 Scott Cooper 博士、医学博士和 Paul 领导 Tuite，医学博士。临床核心将招募 100 名帕金森病 (PD) 患者。与项目 1 和 2 相关的人类受试者协议的深部脑刺激 (DBS) 以及催化剂项目将收集术前基线以及纵向运动和非运动数据。使用 NINDS PD 特定的通用数据元素 (CDE) 以及 DBS 编程数据进行评估。临床核心还将从注册参与者处收集基线生物样本，用于 BioSEND 存储库补充生物统计核心将进入 NINDS 帕金森病生物标志物的 CDE 与罗切斯特大学 Udall 中心和 Sage 合作。生物识别，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 将该应用程序扩展到新的 DBS 患者群体，The Clinical Core 将与该项目密切合作。生物统计、管理和成像核心支持所有中心和项目目标。