Ambulatory Movement Registration in Patients With Deep Brain Stimulation and Continuous Intraduodenal Levodopa Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Bradykinesia score
研究概览
简要总结
In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device. In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing it with written patient diaries.
详细描述
In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ logger (PKG) device which is a movement and acceleration measuring device.
A measurement is done before and after the implantation of selected therapy. PKG will measure automatically in every two minutes the movement of selected limb (usually the more affected upper extremity) for six days. At the same time a patient will keep a written diary of his/her Parkinsonian symptoms. Diary and collected PKG data will be compared. PKG will also remind with vibration the patient of the time drug administration and the patient can confirm this with pressing a button on PKG. The collected data will be transmitted to a computer and analyzed mathematically to produce a visual graph of daily movements. The aim is to evaluate PKG's usability in measuring Parkinsonian symptoms and in evaluation the outcome of DBS and levodopa therapy. Main parameters in evaluation are bradykinesia score and dyskinesia score.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with diagnosed Parkinson's disease
- •Parkinson's disease is in advanced state (defined by the treating physician)
- •A good response with over 30 % improvement of scores in Unified Parkinson's disease rating scale part III in pre-DBS evaluation
排除标准
- •Age older than 70 years (this is a clinical exclusion criteria for DBS treatment)
- •No history of psychosis or depression (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)
- •No diagnosed dementia (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)
结局指标
主要结局
Bradykinesia score
时间窗: 6 months
BKS is summary of bradykinesia presented in PKG recordings, BKS, 0 - 50
次要结局
- Dyskinesia score(6 months)
研究者
Maija Koivu
Specialising physician
Hospital District of Helsinki and Uusimaa
