Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke (RECOMBINE)
Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.
We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Carlo Cereda, MD
- 电话号码:+41 91 811 66 91
- 邮箱:Carlo.Cereda@eoc.ch
研究联系人备份
- 姓名:Paolo Rossi, MD
- 电话号码:+41 091 786 86 86
- 邮箱:paolo.rossi@clinica-hildebrand.ch
学习地点
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Bern、瑞士、3010
- 撤销
- Universitätsspital Bern, Inselspital, Neuropsychologische Rehabilitation
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Brissago、瑞士、6614
- 招聘中
- Clinica Hildebrand, Centro di riabilitazione Brissago
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接触:
- Paolo Rossi, MD
- 电话号码:+41 91 786 86 86
- 邮箱:p.rossi@clinica-hildebrand.ch
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首席研究员:
- Paolo Rossi, MD
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Zihlschlacht、瑞士、8588
- 终止
- HELIOS Klinik Zihlschlacht AG, Neurologisches Rehabilitationszentrum
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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 lesions in the territory of middle cerebral artery subcortical or subcortical/cortical confirmed neuroimaging
- Inclusion must be in the sub-acute phase defined as within 2-4 weeks after stroke
- Persistent hemiparesis, indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) (Brott et al. 1989) but wrist and finger movement is not required
- No UE injury or conditions that limited use prior to the stroke.
- The patient is >18 years old.
- The patient has subscribed the informed consent
Exclusion Criteria:
- History of epilepsy, brain tumor, major head trauma, learning disorder, severe cognitive impairment, drug or alcohol abuse, major psychiatric illness
- Use of medications that may lower seizure threshold (e.g., metronidazole, fluoroquinolones)
- Severe pain in the affected upper limb (>=8 on the shoulder item of the "joint pain during passive motion" of the Fugl-Meyer Assessment Upper Extremity)
- Further stroke or other significant medical complication during the study
- Evidence of severe leucoencephalopathy (grade IV according to the Fazeka's scale)
- Important aphasia that would impair the understanding and performance of the assessment scales
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1 tDCS-Sham
tDC stimulation for 3 weeks, then cross-over to sham stimulation
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Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks
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实验性的:2 Sham-tDCS
Sham stimulation for 3 weeks, then cross over to tDCS stimulation
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Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks
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假比较器:3 Sham-Sham
Treatment for 6 weeks daily with sham stimulation
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Sham stimulation for 30 seconds on 15 days during 6 weeks
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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 |
---|---|---|
Fugl-Meyer Assessment Upper Extremity
大体时间:6 weeks
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Investigator administered questionnaire
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6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Fugl-Meyer Assessment Upper Extremity
大体时间:3 weeks
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Investigator administered questionnaire
|
3 weeks
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Fugl-Meyer Assessment Upper Extremity
大体时间:6 months
|
Investigator administered questionnaire
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6 months
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Barthel Index
大体时间:3 weeks
|
Investigator administered questionnaire
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3 weeks
|
Barthel Index
大体时间:6 weeks
|
Investigator administered questionnaire
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6 weeks
|
Barthel Index
大体时间:6 months
|
Investigator administered questionnaire
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6 months
|
Ashworth scale
大体时间:3 weeks
|
Investigator administered questionnaire
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3 weeks
|
Ashworth scale
大体时间:6 weeks
|
Investigator administered questionnaire
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6 weeks
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Ashworth scale
大体时间:6 months
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Investigator administered questionnaire
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6 months
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Test of Upper Limb Apraxia (TULIA)
大体时间:6 weeks
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investigator administered questionnaire
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6 weeks
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Test of Upper Limb Apraxia (TULIA)
大体时间:6 months
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investigator administered questionnaire
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6 months
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Grip strength
大体时间:3 weeks
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Jamar Hydraulic Hand dynamometer
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3 weeks
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Grip strength
大体时间:6 weeks
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Jamar Hydraulic Hand dynamometer
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6 weeks
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Grip strength
大体时间:6 months
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Jamar Hydraulic Hand dynamometer
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6 months
|
Hamilton depression Rating scale
大体时间:6 weeks
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Patient administered questionnaire
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6 weeks
|
Hamilton depression Rating scale
大体时间:6 months
|
Patient administered questionnaire
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6 months
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合作者和调查者
合作者
调查人员
- 首席研究员:Carlo Cereda, MD、Ospedale Regionale di Lugano - Civico
出版物和有用的链接
一般刊物
- Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
- Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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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