Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke (NEUROSTIM)
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
研究概览
详细说明
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Sao Paulo、巴西、05652-901
- Danielle Boasquevisque
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- Unilateral paresis of upper limb
- National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- Ability to provide written informed consent (patient ou legal representative).
Exclusion Criteria:
- Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- Neurologic diseases except migraine.
- Modified Rankin Scale > 2 prior to stroke.
- Advanced systemic disease such as cancer or advanced chronic renal disease.
- Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
- Contraindication for physical therapy.
- Pregnancy.
- Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
- Comprehension aphasia
- Dementia
- Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Active tDCS+ Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes.
After active session of tDCS, the patient will receive physical therapy for 60 minutes.
Number of treatment sessions: 6 (3 times a week, for 2 weeks)
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Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 60 minutes
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假比较器:Sham tDCS+Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
In sham tDCS, no current will be delivered through the tDCS device.
Physical therapy will be administered for 60 minutes
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety of the intervention as assessed by frequency of adverse events
大体时间:2 weeks
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frequency of adverse events in the active and sham arms
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2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement post treatment as measured by the Modified Rankin Scale
大体时间:2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the NIH Stroke Scale
大体时间:2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Stroke Impact Scale
大体时间:2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
大体时间:2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Modified Ashworth Scale
大体时间:2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Motor Activity Log
大体时间:2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Montreal Cognitive Assessment Test
大体时间:2 weeks and 14 weeks
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No cognitive deterioration post treatment
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2 weeks and 14 weeks
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Structural Connectivity as measured by diffusion tensor imaging analysis
大体时间:2 weeks
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Improvement post treatment
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2 weeks
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Functional Connectivity as measured by resting-state functional magnetic imaging analysis
大体时间:2 weeks
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Improvement post treatment
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2 weeks
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Improvement post treatment as measured by the Barthel index
大体时间:2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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Safety of the intervention as assessed by frequency of adverse events
大体时间:14 weeks
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frequency of adverse events in the active and sham arms
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14 weeks
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Improvement post treatment as measured by Pittsburgh Sleep Quality Index
大体时间:2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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合作者和调查者
调查人员
- 首席研究员:Adriana B Conforto, MD Phd、Hospital Israelita Albert Einstein
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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