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临床试验/NCT02046863
NCT02046863已完成不适用

DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I

Great Lakes NeuroTechnologies Inc.2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming

研究概览

简要总结

The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of idiopathic Parkinson's disease
  • Implanted deep brain stimulation system awaiting initial programming session

排除标准

  • Subjects with significant psychiatric illness or dementia
  • Significant cognitive impairment

结局指标

主要结局

Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming

时间窗: Within two days of standard clinical DBS programming session

Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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