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临床试验/NCT04811066
NCT04811066已完成不适用

The Effect of Multi-session Transcranial Direct Current Stimulation Applied Over the Primary Motor Cortex on Motor Sequence Learning in Parkinson's Disease

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Change from baseline: sequential finger tapping performance

研究概览

简要总结

The present study seeks to examine the efficacy of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.

详细描述

Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions.

The present study seeks to examine the effect of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants will be required to attend eight laboratory sessions, comprising five intervention and three assessment sessions and will be tested on their ability to learn a 16-digit finger tapping sequence with their right hand. Sessions one to five will form the intervention and will be performed at the same time on consecutive days (i.e. mon-fri). In addition, session one will double as a baseline assessment and intervention session. Assessments sessions will be performed once before the intervention (session one), and three times following the intervention on day three, one week, and four weeks post intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Right-handed (Edinburgh Handedness Inventory; ≥50)
  • Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
  • Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
  • On stable dopaminergic medication

排除标准

  • History of stroke
  • Comorbidity
  • Cephalic implants

结局指标

主要结局

Change from baseline: sequential finger tapping performance

时间窗: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.

A skill index reflecting the accuracy and speed that participants perform a specified finger tapping sequence.

Change from baseline: shape-counting error

时间窗: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied.

The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.

次要结局

  • Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3)(Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention)
  • Change from baseline: Purdue pegboard task performance(Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention)
  • Change from baseline: oxygenated haemoglobin response(Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention)
  • Change from baseline: upper limb motor task performance(Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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