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临床试验/NCT02158312
NCT02158312Unknown1 期

Bihemispheric Modulation of the Motor Cortex by Single-session Transcranial Direct Current Stimulation During Training in Subacute Stroke Patients

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
30
试验地点
1
主要终点
transcranial magnetic stimulation (TMS)

研究概览

简要总结

Post-stroke sensorimotor recovery largely depends on ipsilesional and interhemispheric motor circuit reorganization. Transcranial direct current stimulation (tDCS) may be used to enhance after-effects of rehabilitation through membrane polarization modulation. In this double-blind, crossover randomized controlled trial, we aim to investigate whether single-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy modulates ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.

详细描述

We will consecutively enroll subacute (2-4 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be assessed for baseline upper extremity motor function (Fugl-Meyer test and Action Research Arm test), structural and functional magnetic resonance imaging (fMRI). A single session of bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or sham tDCS (same but stimulation for only 2 min) with simultaneous physical/occupational therapy will be tested in each subject with a randomized sequence on different days (at least two days apart from each other). All stroke patients will receive standard medical and rehabilitation treatments during the study period. Changes in corticospinal excitability and transcallosal inhibition from the TMS study, as well as sensorimotor oscillations, MEG source projection, and functional connectivity from the task-related MEG will be assessed immediately before and after intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

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
否

入选标准

  • •subacute (2-4 weeks after stroke onset) patients
  • •first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory
  • •mild to moderate hand weakness (MRC 2-4/5)

排除标准

  • •cerebral cortex lesions
  • •containing metal implants (such as implanted electrodes, pacemakers)
  • •sensitive or fear of electromagnetic waves
  • •pregnant women
  • •history of alcohol or drug abuse
  • •history of seizures or epilepsy EEG recording
  • •other significant disease or neuropsychiatric disorders
  • •claustrophobia
  • •fixed dentures over two or more (enough to interfere with MEG signals)

研究组 & 干预措施

transcranial direct current stimulation

Experimental

bihemispheric transcranial direct current stimulation, anodal at ipsilesional M1 while cathodal at contralesional M1, for 20 minutes

干预措施: Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK) (Device)

sham stimulation

Placebo Comparator

same as the experimental stimulation condition but only for 2 minutes

结局指标

主要结局

transcranial magnetic stimulation (TMS)

时间窗: up to 20 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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