Application of High-definition Transcranial Electrical Stimulation in the Upper Extremity Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
研究概览
简要总结
Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However,the existing tCES products effect on the whole brain networks and lack special waveforms. Therefore, we aim to develop a wearable tCES with high definition and special waveforms in this study. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. We expect that the novel high-definition tCES (HD-tCES) combined with the upper extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years.
- •Unilateral cerebral stroke with hemiplegia in Brunnstrom stage III-V.
- •6 months to 5 years after stroke.
- •Muscular inelasticity (spasticity) 1-3 on the affected upper limb, evaluated by the Modified Ashworth Scale.
排除标准
- •Extremely sensitive to electrical stimulation and cannot tolerate it.
- •Contracture on upper extremities, and limitation in joint range of motion.
- •The muscle tone was severe spasticity,
- •Ossification or inflammation in muscle tissue.
- •A history of cardiopulmonary disease or arrhythmia.
- •With implantable medical electronic devices, like pacemaker.
- •Pressure sores or wounds on the skin of head and upper extremities.
- •Metal implants in the head (neck).
- •Severe cognitive or psychiatric disorders, such as schizophrenia or dissociative identity disorder.
- •A history of seizure or other brain pathology.
- •Brain surgery or severe brain trauma.
- •Drug or alcohol abuse.
- •Malignant neoplasm or rheumatism disorder, like SLE, RA, or AS.
结局指标
主要结局
Change from baseline in the Fugl-Meyer Assessment upper extremity scale (FMA-UE) after intervention
时间窗: Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session)
The FMA-UE assesses motor functioning of upper extremity. Each movement is estimated by a 3-point scale (0-1-2). The total score of the FMA-UE is 66, and a higher score indicates that the patient has better movement ability.
次要结局
- Change from baseline in the Wolf Motor Function Test (WMFT) after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session))
- Change from baseline in the Modified Ashworth Scale (MAS) after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session))
- Change from baseline in the Jebsen-Taylor Hand Function Test (JTT) after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session))
- Change from baseline in the Finger to Nose Test after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 4-week intervention (within 7 days after the last intervention session))
- Incidence of treatment-emergent adverse events [safety and tolerability](Within 10 minutes after each intervention session (a total of 12 sessions, 3 sessions/week, lasting 4 weeks))