DiSCERN Phase I - Objective Quality of Life Detection Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Kinesia Symptom Scores during Daily Wear
研究概览
简要总结
The purpose of this research study is to:
- Collect data to use in the development of a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) such as deep brain stimulation (DBS) and drug pumps.
- Determine the level to which specific activities reflect with quality of life in individuals with PD.
- Obtain feedback from individuals with Parkinson's disease and clinicians on the usability of the system.
详细描述
The investigators aim to develop a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) and identify when AT recipients are in need of a therapy adjustment. This system will integrate ambulatory PD monitoring with context aware activity detection as the daily activities a patient performs are often the best predictors of quality of life (QoL). In this study the Kinesia 360 system will collect motion data to measure tremor, bradykinesia (slow movement), and dyskinesia (involuntary movements) from individuals with PD to track their symptoms throughout the day. A smartphone will collect information on subject location and activity using the GPS, accelerometers, and microphone within the phone to find correlations between activity and patient wellness. This data will be used to improve detection over time and predict whether patients are candidates for advanced therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Diagnosed with PD
- •Hoehn and Yahr scale I-III
- •Able to travel to Great Lakes NeuroTechnologies
- •Ambulatory and capable of using the Kinesia 360 system
- •Able to understand and follow instructions regarding using the device
排除标准
- •Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.
结局指标
主要结局
Kinesia Symptom Scores during Daily Wear
时间窗: Continuous during wear over four days
Kinesia 360 scoring of Parkinson's Disease motor symptoms (tremor, slowness, dyskinesia, gait): The Kinesia 360 system translates recorded motion into 0-4 scores that correlate to rating scales used by clinicians (lower scores are signifiers of better outcomes and higher scores signify worse outcomes). A separate 0-4 score is generated for tremor, slowness, and dyskinesia, and gait is tracked for step count and percent of day walking.
次要结局
- User environment audio activity(Continuous during wear over four days)
- Patient physical activity(Continuous during wear over four days)
- Patient locations and travel(Continuous during wear over four days)