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临床试验/NCT02600858
NCT02600858已完成不适用

Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease

University of Utah2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)

研究概览

简要总结

The study determines whether standard medical care (dopamine) affects learning and retention of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on the feeding task generalises to performance on an untrained upper limb buttoning task. Half the participants will train on the feeding task after they have taken their first dose of dopamine for the day (i.e. "on" medication state), while the other half will train on the same feeding task before taking their first daily dose of dopamine (i.e. "off" medication state).

详细描述

Parkinson disease (PD) is an age related neurodegenerative disorder with symptomatic declines in motor function due to a loss of dopaminergic neurons within the basal ganglia.

Ironically, treatment with exogenous dopamine-replacement medication (e.g. levodopa) may have positive effects on existing motor skills such as handwriting or walking, but may have detrimental effects on the learning of motor skills necessary for effective rehabilitation.

Although dopamine medications are routinely prescribed to replace lost dopamine in the sensorimotor areas of the striatum, they may actually be "overdosing" the associative striatum, a candidate neuroanatomical correlate for motor learning. To date, however, this 'overdose' hypothesis has not been widely tested, given that few studies of motor learning in PD have reported or controlled for whether individuals were tested "on" or "off" their dopamine replacement medication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic Parkinson's disease confirmed by neurologist
  • Hoehn and Yahr stages 1 to 3
  • On a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month
  • Walks unaided

排除标准

  • Not taking dopamine replacement therapy
  • With prior surgical management for PD (e.g. deep brain stimulation)
  • With medication-resistant freezing of gait
  • Significant cognitive impairment (Montreal Cognitive Assessment score <18)
  • Unstable medical conditions
  • Other neurological conditions
  • Unable to follow instructions or safely complete the training tasks

研究组 & 干预措施

Training "off" medication

Experimental

Participants will train on the upper limb feeding task before taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "off" dopamine replacement medication

干预措施: Upper limb feeding training (Behavioral)

Training "on" medication

Other

Participants will train on the upper limb feeding task after taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "on" dopamine replacement medication

干预措施: Upper limb feeding training (Behavioral)

结局指标

主要结局

Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)

时间窗: Day 8 (i.e. 48 hours after the last block of training)

次要结局

  • Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)(Day 5, Day 15 (i.e. 9 hours after the last block of training))
  • Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)(Day 5, Day 8 (i.e. 48 hours after the last block of training))
  • Buttoning task score(Day 15 (i.e. 9 days after the last block of training))
  • Rate of improvement(Day 1 through Day 3)
  • Nine hole peg test score(Day 15 (i.e. 9 days after the last block of training))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee Dibble

Associate Professor

University of Utah

研究点 (2)

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