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临床试验/NCT00792428
NCT00792428已完成不适用

Facilitating Motor Recovery After Stroke Using tDCS

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Fugl-Meyer Assessment of Upper Extremity Motor Impairment

研究概览

简要总结

The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.

研究设计

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

入排标准

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

入选标准

  • First time clinical ischemic stroke or cerebrovascular accident
  • At least 5 months out from first ischemic stroke prior to study enrollment

排除标准

  • More than 1 stroke (older strokes)
  • Significant pre-stroke disability
  • A terminal medical illness or disorder with survival of less than 1 year
  • Co-existent major neurological or psychiatric diseases (e.g., epilepsy)
  • Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents
  • Active participation in other stroke recovery trials testing interventions

研究组 & 干预措施

Real-tDCS + PT-OT

Active Comparator

Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.

干预措施: Real Transcranial Direct Current Stimulation (Device)

Sham-tDCS + PT-OT

Sham Comparator

Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.

干预措施: Sham Transcranial Direct Current Stimulation (Device)

结局指标

主要结局

Fugl-Meyer Assessment of Upper Extremity Motor Impairment

时间窗: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days

This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.

次要结局

  • Wolf-Motor-Function-Test(Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gottfried Schlaug

Associate Professor of Neurology; Staff Neurologist

Beth Israel Deaconess Medical Center

研究点 (2)

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