SAFETY OF NEUROSTIMULATION IN EARLY PARKINSON'S DISEASE

早期帕金森病神经刺激的安全性

• 批准号: 7605585
• 负责人: DAVID CHARLES
• 金额: $ 1.79万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605585
• 关键词: Bilateral; Chronic; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Condition; Data; Data Collection; Deep Brain Stimulation; Early treatment; Frequencies; Funding; Grant; Informed Consent; Institution; Length; Measures; Outcome Measure; Parkinson Disease; Parkinsonian Disorders; Pharmaceutical Preparations; Pharmacotherapy; Pilot Projects; Procedures; Recruitment Activity; Research; Research Design; Research Personnel; Resources; Safety; Sample Size; Source; Structure of subthalamic nucleus; Testing; Time; United States National Institutes of Health; data management; patient safety

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We propose a pilot study designed to provide the necessary preliminary data to support a subsequent full-scale clinical trial that will test the hypothesis that chronic high frequency deep brain stimulation (DBS) of the bilateral subthalamic nuclei (B-STN) is a safe and effective treatment to slow the progression of PD. Specific Aim #1: To compare the safety and tolerability of B-STN DBS and optimal drug therapy (ODT) to ODT alone in early Parkinson's disease. Specific Aim #2: To determine the minimum length of time a subject must remain off medication and stimulation (washout period) to measure the fully untreated parkinsonian state ("OFF" condition). Specific Aim #3: To demonstrate that it is possible to recruit, provide meaningful informed consent, and retain subjects with early PD in a long-term clinical trial of B-STN DBS for the treatment of early PD. Specific Aim #4: To provide the data necessary to estimate sample size for a subsequent full-scale clinical trial of safety and efficacy. Specific Aim #5: To test the data management procedures for a subsequent full-scale clinical trial of safety and efficacy. Specific Aim #6: To test specific safety and patient outcome measures to inform data collection for a subsequent full-scale trial of safety and efficacy.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 我们提出了一项试点研究，旨在提供必要的初步数据，以支持随后的全尺度临床试验，该试验将检验以下假设：慢性高频深脑刺激（DBS）是双侧下丘脑核（B-STN）是一种安全有效的治疗，可以减缓PD的进展。 具体目的1：比较B-STN DBS和最佳药物治疗（ODT）的安全性和耐受性与早期帕金森氏病的ODT。 特定目的＃2：要确定受试者必须保持药物和刺激（洗涤期）的最小长度，以测量未经处理的帕金森氏症状态（“关闭”状态）。 特定目的＃3：证明可以在B-STN DBS的长期临床试验中招募，提供有意义的知情同意并保留具有早期PD的受试者，以治疗早期PD。 特定目的＃4：提供必要的数据来估算样本量，以进行随后的安全性和功效的全尺度临床试验。 具体目标＃5：测试数据管理程序，以进行随后的安全性和功效的全面临床试验。 特定目标＃6：测试特定的安全性和患者结果指标，以告知数据收集，以进行随后的安全性和功效的全面试验。