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临床试验/NCT04185740
NCT04185740已完成2 期

The Stability in Medication Responsiveness During Research Experiments in Parkinson's Disease

KU Leuven2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年7月25日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
KU Leuven
入组人数
33
试验地点
2
主要终点
Tap frequency

研究概览

简要总结

Up till now, dopaminergic replacement is considered as the gold standard for the symptomatic treatment of motor symptoms in Parkinson's disease (PD). However, the intake, especially higher doses when taken for a longer duration, are associated with several side effects including response fluctuations. These fluctuations in medication response are often characterized by a wearing-OFF period, also defined as the recurrence of PD symptoms before a patient should take the next dose of medication. The duration of test sessions during research experiments (e.g. in the field of rehabilitation) can interfere with the period of the optimal therapeutic effect of dopaminergic medication, influencing outcomes of a study. Therefore, the objective of this project is to get more insight in the measurability of ON-OFF fluctuations by testing the applicability of a short and simple timed tapping task (TTT) on a smartphone in rehabilitation research studies. The assessment can be useful for future clinical studies in PD where a precise estimation of medication is indispensable for accurate research outcomes.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • A diagnosis of PD, based on the UK Brain Bank Diagnostic Criteria
  • Hoehn & Yahr stage I-III
  • Mini Mental State Examination (MMSE) scores >24
  • Right-handedness
  • No other known disease or disorder that will interfere with the experiments

排除标准

  • 未提供

结局指标

主要结局

Tap frequency

时间窗: 7 days

Taps per second

Actual distance between taps

时间窗: 7 days

Inter-tap distance in centimeters

Visual analogue scale (VAS)

时间窗: 7 days

To indicate the subjective medication responsiveness (current golden standard to measure medication fluctuations)

Mean hand movement time between taps

时间窗: 7 days

Inter-tap time in milliseconds

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice Nieuwboer

Principal Investigator

KU Leuven

研究点 (2)

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