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临床试验/NCT03635008
NCT03635008Unknown不适用

Effects of Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients With Severe Upper Extremity Hemiparesis: Study Protocol for a Randomized Controlled Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Fugl-Meyer Assessment (FMA) scores of the upper extremity

研究概览

简要总结

Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. And the studies using the noninvasive stimulation in subacute stroke is lack. In addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke.

In this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. Interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tDCS) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. Control group will receive the same treatment except for sham tDCS instead of anodal tDCS over the contralesional premotor area. Functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). Cortical activation pattern will be measured by the electroencephalography (EEG) at baseline and immediately after the intervention.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

An investigator who applies the tDCS to the participants will not be masked. However, other investigators including outcome assessors and participants will be masked. The other care providers in our department (e.g. other physio- or occupational therapists) will be masked.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-85 years old
  • Ischemic or Hemorrhagic stroke confirmed by the MRI or CT
  • First-ever stroke
  • < 3 months after stroke
  • Unilateral upper limb weakness due to the stroke and meets the following all conditions: (1)Shoulder Abduction Finger Extension (SAFE) score (range 0-10) revealing the motor paralysis is below 8 (lower score mean worse function)), (2)Fugl Meyer Assessment score in the affected upper extremity is 25 or under
  • (3)No response in the motor evoked potential recorded on the affected extensor carpi radialis muscle,

排除标准

  • recurrent stroke
  • history of the other brain injury (e.g. traumatic brain injury)
  • poor cognitive function (score of korean version of mini-mental state exam is 15 or below 15).
  • Poor cooperation due to delirium or problems in the consciousness
  • Uncontrolled or unstable medical conditions.
  • Scalp problems which interfere with the tDCS application
  • Robotic arm training can not be applied due to the unstable sitting posture or head control, or arm pain.
  • Metals in the head (e.g. clip, coil)
  • Cardiac pacemaker or cochlear implants

结局指标

主要结局

Fugl-Meyer Assessment (FMA) scores of the upper extremity

时间窗: Change from Baseline FMA at 2 weeks

range: 0 (worst) -66 (best)

次要结局

  • Modified Ashworth Scale(6 weeks after baseline)
  • Manual muscle power test(6 weeks after baseline)
  • Fugl-Meyer Assessment (FMA) scores of the upper extremity(Change from Baseline FMA at 6 weeks)
  • Korean version of modified Barthel Index (K-MBI)(Change from baseline K-MBI at 6 weeks)
  • Brunnstrom stage (B-stage) of arm(Change from baseline B-stage at 6 weeks)
  • Laterality Index(6 weeks after baseline)
  • Box and Block Test (BBT)(Change from baseline BBT at 6 weeks)

研究者

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

Won-Seok Kim

Assistant Professor

Seoul National University Bundang Hospital

研究点 (2)

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