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Motor Learning and Multi-session tDCS in Parkinson's Disease

2022年6月10日 更新者:The Hong Kong Polytechnic University

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

48

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Hung Hom
      • Hong Kong、Hung Hom、香港
        • The Hong Kong Polytechnic University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of stroke
  • Comorbidity
  • Cephalic implants

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
假比较器:Sham tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. Stimulation was phased in for 30 seconds up to 2 mA and then switched off. Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation.

Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.

Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.

其他名称:
  • 时间点DCS
实验性的:Anodal tDCS
Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.

Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.

Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.

其他名称:
  • 时间点DCS
实验性的:Cathodal tDCS
Cathodal electrode (35 cm2 sponge electrode) placed over C3. Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.

Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.

Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.

其他名称:
  • 时间点DCS

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline: sequential finger tapping performance
大体时间: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.
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.
Change from baseline: shape-counting error
大体时间: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.
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.

次要结果测量

结果测量
措施说明
大体时间
Change from baseline: oxygenated haemoglobin response
大体时间:Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3)
大体时间:Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Participants physical function is assessed according to the criteria of the Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3). Minimum value = 0, maximum value = 132. Lower scores indicate a better outcome.
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
大体时间:Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Timed sequential movement of the arm and hand. The participant sits upright on a chair that has no arm support with their arms relaxed by their side. The time taken to perform the following sequence 10 times is recorded: 1. Close and open hand, 2) flex elbow, 3) close and open hand, 4) extend elbow. Right and left arms are assessed separately.
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
大体时间:Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention
Participants are required to pick up a metal peg and place the peg in a specified row of holes. Pegs must be placed one at a time. The maximum number of pegs placed within 30 seconds is recorded. The assessment is repeated three times for each hand. Each hand is assessed separately.
Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Margaret Mak, Dr、The Hong Kong Polytechnic University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月19日

初级完成 (实际的)

2021年10月2日

研究完成 (实际的)

2021年10月2日

研究注册日期

首次提交

2021年3月19日

首先提交符合 QC 标准的

2021年3月19日

首次发布 (实际的)

2021年3月23日

研究记录更新

最后更新发布 (实际的)

2022年6月13日

上次提交的符合 QC 标准的更新

2022年6月10日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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