A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Quantify Tolerance to Deep Brain Stimulation in Essential Tremor Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acquire high-quality physiological signal characteristics from movement disorder patients.
研究概览
简要总结
The purpose of this research is to observe the daily loss of benefit from DBS therapy by performing a standardized set of tasks throughout the day while wearing an Apple Watch to collect movement and other physiological data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients with well-classified essential tremor, who are already receiving regular DBS therapy at Mayo Clinic for their movement disorder.
- •Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
- •Patient agrees to perform daily tasks in BrainRISE app and consents to the study collecting video and audio recordings during those tasks.
- •Proficient in the use of a smart phone.
排除标准
- •Cognitive or psychiatric condition rendering a patient unable to cooperate with data collection, or to manage and recharge smart watch and tablet computer devices.
- •Presence of open or healing wounds near monitoring sites (infection risk).
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
结局指标
主要结局
Acquire high-quality physiological signal characteristics from movement disorder patients.
时间窗: 12 Months
Acquisition of high-quality physiological signals from 50 subjects with movement disorders over the course of two weeks and up to thirty subjects over one day with 90% compliance rate as determined by the number of study tasks completed by participants.
Acquire high-quality physiological tremor signals from movement disorder patients.
时间窗: 12 Months
Measured by wrist accelerometry, which tracks the acceleration of the patients' wrists and is reported in m/sec\^2 on a scale where 1.0 = 9.8m/s\^2.
次要结局
- Subject feedback(12 Months)
研究者
Bryan T. Klassen, M.D.
Principal Investigator
Mayo Clinic