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临床试验/NCT02701803
NCT02701803已完成不适用

Ambulatory Movement Registration in Patients With Deep Brain Stimulation and Continuous Intraduodenal Levodopa Therapy

Hospital District of Helsinki and Uusimaa1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年10月最近更新:
适应症

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

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

发起方
Hospital District of Helsinki and Uusimaa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maija Koivu

Specialising physician

Hospital District of Helsinki and Uusimaa

研究点 (1)

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