Combine Transcranial Direct Current Stimulation and Neuromuscular Electrical Stimulation on Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Movement performance assessment
研究概览
简要总结
Transcranial direct current stimulation (tDCS) has been shown not only to improve motor function but also increase cortical excitability and neural plasticity. Several studies demonstrated that the combination of tDCS and different treatments are more effective than a single tDCS alone. However, the effects of combination tDCS and neuromuscular electrical stimulation (NMES) on upper extremity motor recovery in patients with stroke have not yet been investigated. Taking into consideration the safety and feasibility of new medical technology, recruitment of healthy subjects as a pilot study. And then recruit the stroke patients to investigate the effects for the combination of tDCS and NMES on upper extremity motor recovery in stroke.
详细描述
The Transcranial direct current stimulation (tDCS) and neuromuscular electrical stimulation (NMES) is non-invasive electrical stimulation, and some studies have proved efficacy of the tDCS and NMES on healthy subjects and stroke patients. However, the effects of combination tDCS and NMES on upper extremity motor recovery and neural plasticity in healthy subjects and patients with stroke have not yet been investigated. Moreover in order to discover the tDCS combine NMES of the safety and feasibility and influences on neural plasticity and motor function, the cortical excitability and functional recovery measurements (clinical scales) are taken in the healthy subjects and stroke.
The right-handed subjects will be received the combination of tDCS and NMES for 30 minutes. The changes in the hand function and cortical excitability were probed by recording movement performance scales in upper extremity and mapping of brain cortex before and after the intervention.
The patients will be assigned into one of three groups (A, B,C) by block randomization. All participants will receive regular traditional rehabilitation. In addition, three groups will receive an additional 3 weeks, 5 times per week, 30 minutes once daily, total 15 session. Group A: both tDCS and NMES conduct simultaneously for 30 minutes. Group B: combination of tDCS and sham NMES Group C: combination of sham tDCS and sham NMES.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(healthy subjects):
- •Age: 20~65 years old
- •Who are willing to participate in the experiment
- •Signed the consent
- •Right handed
排除标准
- •(healthy subjects):
- •Musculoskeletal pathology or neurological disorders affecting movements in the upper limbs
- •Epilepsy or family history
- •Cardiac pacemaker
- •Metallic implant in the head
- •Sensory complete injury in upper limb
- •Had brain surgery
- •Expected to conduct brain surgery and major surgery during the experiment
- •The patients is suitable for the experiment by investigator assessedInclusion
- •Inclusion Criteria(stroke):
- •Signed the informed consent
- •First-ever ischemic stroke
- •Stroke at least 6 months
- •Unilateral hemiplegia
- •No severe cognitive impairment (National Institutes of Health Stroke Scale-Level of Consciousness: 0, Level of Consciousness Questions: 0, Level of Consciousness Commands: 0)
- •Sit on a chair for more than 30 minutes independently
- •Brunnstrom recovery stage≧3 in the paretic hand
- •Muscle tone at the wrist flexor with a modified Ashworth scale≦2
- •Exclusion Criteria(stoke):
- •Speech disorder or global aphasia
- •Musculoskeletal pathology or neurological disorders affecting movements in the paretic upper limbs
- •Epilepsy or family history
- •Cardiac pacemaker
- •Metallic implant in the head
- •Diabetic, peripheral vascular disease or neuropathy that attributable to sensory complete injury
- •Have intracranial space occupied lesion, ex: brain tumors, arteriovenous malformations
- •Had brain surgery
- •Meningitis and encephalitis
- •Expected to conduct brain surgery and major surgery during the experiment
- •The patients is suitable for the experiment by investigator assessed
研究组 & 干预措施
Combination of tDCS and NMES
Both tDCS and NMES conduct simultaneously for 30 minutes.
干预措施: Combination of tDCS and NMES (Device)
Combination of tDCS and sham NMES
Both tDCS and sham NMES conduct simultaneously for 30 minutes. Sham NMES electrodes are placed away from all motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation.
干预措施: Combination of tDCS and sham NMES (Device)
Combination of sham tDCS and sham NMES
Both sham tDCS and sham NMES conduct simultaneously for 30 minutes. Shame tDCS is started in a ramp-like fashion but fade out slowly after 30 seconds.
Sham NMES electrodes are placed away from all motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation.
干预措施: Combination of sham tDCS and sham NMES (Device)
结局指标
主要结局
Movement performance assessment
时间窗: Change from baseline motor performance at 3 weeks, 1 month and 6 months.
Movement performance assessment by clinical motor assessment scales in upper extremity executed by qualified physiotherapy in 3 groups.
次要结局
- Mapping of brain cortex(Change from baseline motor performance at 3 weeks, 1 month and 6 months.)
研究者
Jau-Hong Lin, Professor
Professor in Department of Physical Therapy, Kaohsiung Medical University, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital