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临床试验/NCT01005394
NCT01005394终止不适用

Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke

Nexstim Ltd1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
1
主要终点
navigated transcranial magnetic stimulation examination and correlation with motor functional testing

研究概览

简要总结

The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help "re-wire" the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in brain activity during the first 6 months after stroke (to determine how the brain "re-wires"); 2) compare changes in recovery of motor function with changes in brain re-wiring; 3) determine the ability of TMS to "predict" functional outcome in the first 6 months after stroke.

The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes at 3 and 6 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • one sided ischemic stroke confirmed by radiology
  • 20-80 years old

排除标准

  • hemorrhagic stroke
  • brainstem stroke
  • cerebellar stroke
  • thalamic stroke
  • seizure with the recent stroke
  • any history of uncontrolled seizure
  • history of epilepsy
  • pregnancy or planning on getting pregnant during the next year
  • MRI incompatibility (e.g. metal implants in body)
  • recent history (past year) of alcohol and drug abuse (due to lack of follow up)
  • Other criteria include TMS exclusions: aneurysm clips, previous surgery over motor cortex, open craniotomy

结局指标

主要结局

navigated transcranial magnetic stimulation examination and correlation with motor functional testing

时间窗: Enrollment, week 2, week 4 , week 12 and week 24 post-stroke

次要结局

  • Safety of navigated transcranial magnetic stimulation examination(each examination)

研究者

发起方
Nexstim Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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