Transcranial Direct Current Stimulation for Freezing of Gait (TDCS-FOG)
2020年6月16日 更新者:Corneliu C Luca、University of Miami
Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease
This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).
研究概览
研究类型
介入性
注册 (实际的)
9
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
-
-
Florida
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Miami、Florida、美国、33136
- University of Miami
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-
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
18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:
- age 18- 80
- Parkinson's disease stages 2-3 Hoehn and Yahr.
- Presence of Freezing of Gait
- Stable medication regimen
- Time to complete TUG >12 seconds
Exclusion Criteria:
- medical condition that would interfere with walking and training for 30 minutes
- unable to perform timed up and go in the off condition
- history of seizures
- implanted deep brain stimulator, pacemaker or any other electronic device.
- dementia
- Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:tDCS+ LT
Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.
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Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.
其他名称:
An individualized dual-task walking program for approximately 30 minutes.
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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 in Walking Speed
大体时间:baseline, 3 weeks
|
walking speed will be measured using sensors during a 90 second walk
|
baseline, 3 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)
大体时间:baseline, 3 weeks
|
UPDRS motor score range from 0-56 with higher scores indicating greater impairment.
|
baseline, 3 weeks
|
Change in Stride Length
大体时间:baseline, 3 weeks
|
Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.
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baseline, 3 weeks
|
Change in Postural Sway
大体时间:baseline, 3 weeks
|
Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.
|
baseline, 3 weeks
|
Change in Timed Up-and-Go (TUG) Time
大体时间:baseline, 3 weeks
|
Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.
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baseline, 3 weeks
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Change in Motor Threshold
大体时间:baseline, 3 weeks
|
Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area.
The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.
|
baseline, 3 weeks
|
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio
大体时间:baseline, 3 weeks
|
Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).
|
baseline, 3 weeks
|
Change in Backward Digit Span
大体时间:baseline, 3 weeks
|
Digit span is measured by total number of correct digits recited.
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baseline, 3 weeks
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Change in the Trail Making Test Time
大体时间:baseline, 3 weeks
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Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.
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baseline, 3 weeks
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Change in the Montreal Cognitive Assessment (MOCA)
大体时间:baseline, 3 weeks
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The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.
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baseline, 3 weeks
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Change in the Auditory Consonant Trigrams Test (ACT)
大体时间:baseline, 3 weeks
|
The ACT has a score from 0-60 with higher score indicating better performance.
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baseline, 3 weeks
|
Change in the Freezing of Gait Questionnaire (FOG-Q)
大体时间:baseline, 3 weeks
|
The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.
|
baseline, 3 weeks
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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:Corneliu Luca, MD, PhD、University of Miami
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)
2014年9月12日
初级完成 (实际的)
2018年6月27日
研究完成 (实际的)
2018年6月27日
研究注册日期
首次提交
2014年10月7日
首先提交符合 QC 标准的
2014年10月10日
首次发布 (估计)
2014年10月16日
研究记录更新
最后更新发布 (实际的)
2020年6月30日
上次提交的符合 QC 标准的更新
2020年6月16日
最后验证
2020年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.