Cerebellar rTMS to Improve Gait Recovery
2018年3月5日 更新者：Giacomo Koch、I.R.C.C.S. Fondazione Santa Lucia
Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial
The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions.
Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery.
In this randomized, double blind, sham-controlled trial we aim to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery
研究概览
研究类型
介入性
注册 (实际的)
40
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
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Rome、意大利、00179
- Santa Lucia foundation
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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
30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:
- First ever-chronic ischemic stroke, i.e. at least 6 months after the stroke event,
- Left or right subcortical or cortical lesion of the middle cerebral artery with medium-severity stroke NHISS <15 (All lesions must be documented by magnetic resonance imaging (T1- and T2-weighted images; 1.5T, GE scanners)
- No contraindication to brain MRI
- MEP recordable in order to evaluate the resting motor threshold (RMT)
Exclusion Criteria:
- Epilepsy
- Severe general impairment or concomitant diseases (tumors, etc.)
- Age> 80 years
- Infections in progress
- Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
- Treatment with benzodiazepines, baclofen, antidepressants, clonidine, beta blockers and other potentially interfering drug treatments on plasticity phenomena.
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 |
|---|---|
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有源比较器：Cerebellar iTBS
Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
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theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models.
Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
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假比较器：Sham iTBS
Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
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theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models.
Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
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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 |
|---|---|---|
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Berg Balance Scale (BBS) for gait and balance
大体时间：Change from baseline at the end of three weeks treatment
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Assessment of gait and balance functions
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Change from baseline at the end of three weeks treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fugl-Meyer Assessment (FMA) scale
大体时间：Change from baseline at the end of three weeks treatment
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Assessment of motor functions
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Change from baseline at the end of three weeks treatment
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Barthel Index (BI)
大体时间：Change from baseline at the end of three weeks treatment
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Assessment of functional abilities
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Change from baseline at the end of three weeks treatment
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Neurophysiological assessment of cortical activity
大体时间：Change from baseline at the end of three weeks treatment
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evaluation of cortical activity by means of TMS in combination with EEG
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Change from baseline at the end of three weeks treatment
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Gait analysis
大体时间：Change from baseline at the end of three weeks treatment
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evaluation of locomotion
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Change from baseline at the end of three weeks treatment
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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3月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年10月1日
研究注册日期
首次提交
2018年2月19日
首先提交符合 QC 标准的
2018年3月5日
首次发布 (实际的)
2018年3月7日
研究记录更新
最后更新发布 (实际的)
2018年3月7日
上次提交的符合 QC 标准的更新
2018年3月5日
最后验证
2018年3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.