ACTRN12613000109707尚未招募2 期
A pilot investigation of the effect of cathodal transcranial direct current stimulation (ctDCS) plus standard upper limb rehabilitation to augment motor recovery post acute stroke.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years(—)
- 性别
- All
入选标准
- •All ischaemic strokes admitted to Sir Charles Gairdner Hospital under a consultant neurologist will be screened. A total of 37- 40 participants will be recruited for this study.
- •All subjects must meet the following inclusion criteria:
- •1. First ever ischaemic stroke (cortical or subcortical involving the territory of the middle cerebral artery (MCA) based on imaging findings.
- •2. Stroke onset less than 1 week prior to study enrolment.
- •3. Moderate to severe hemiparesis based on the Fugl Meyer Upper Extremity assessment (35-52 moderate and less than 35 severe upper limb deficit).
- •4. Detectable motor evoked potentials (MEPs) in the affected hand muscles via TMS assessment.
- •5. Stable blood pressure parameters within limits approved by treating neurologist.
- •6. Age between 18 to 80 years old.
- •7. MMSE greater than 24
排除标准
- •1. Pre-existing upper limb impairment causing functional limitation
- •2. Hemiplegic shoulder pain
- •3. Metallic foreign body implant (pacemaker or artificial cochlea)
- •4. History of seizure or another unstable medical condition
- •5. Pregnancy
- •6. Severe language disturbance (Frenchay Aphasia Screening Test will be used to identify participants with communication difficulties; a more detailed evaluation will be performed by a speech pathologist to determine severity of language impairment).
- •7. English as a second language
- •8. Severe Neglect (score of < 44 out of 54 points on the Star Cancellation test)
- •9. History of depression, alcohol or drug abuse
- •10. Coexistent neurological or psychiatric disease
- •11. Current treatment with antidepressants, antipsychotics or benzodiazepines
- •12. Current treatment with Na+ or Ca 2+ Channel blockers or N-methyl-D-aspartate (NMDA) receptor antagonists.
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