Series Study About the rTMS Effects on the Recovery of Limb Motor Dysfunction Due to Cerebral Vascular Disease, Part 1: Comparing the Effects of Various Combinations Between 6 Hertz(Hz) rTMS & LFrTMS.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Fugl-Meyer assessment (FMA)
研究概览
简要总结
To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb motor dysfunction due to cerebral vascular disease.
详细描述
It is the basic principle for functional recovery after cerebrovascular disease to restore the original balance in reciprocal inhibition between affected hemisphere and unaffected hemisphere.
repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuroplastic technique rebalancing interhemispheric competition after stroke. Low frequency rTMS (LFrTMS) on contralesional hemisphere or high frequency rTMS (HFrTMS) on lesional hemisphere might be the basic choice.
6 hertz(Hz) primed LFrTMS on lesional primary motor cortex has the stronger effect than LFrTMS alone does on one hand; the other newly-developed combination, i.e. HFrTMS on lesional primary motor cortex and LFrTMS on contralesional primary motor cortex might also be more effective than they do respectively on the other hand.
The main aim of our research is to find out which combination is better by considering both safety and efficiency.
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
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 30 to 90 years;
- •Newly onset cerebral infarction or brain hemorrhage confirmed by MRI or CT;
- •the disease duration is less than 20 weeks when recruited into the trial;
- •no existence of limb motor dysfunction before this onset, and new occurrence of unilateral limb motor dysfunction after this onset;
- •the physical and mental condition are good enough to cooperate with the assessment and treatment;
- •the NIHSS score: total 5-20,1a,1b,1c=0;
- •the subject or legal guardian sign the consent form.
排除标准
- •during pregnancy;
- •with skull defect;
- •with metal implants, cardiac pacemaker, cochlear implantation;
- •epileptiform discharge in EEG.
结局指标
主要结局
Fugl-Meyer assessment (FMA)
时间窗: 1) Before treatment (Baseline); 2) Change from Baseline FMA at the 1st workday after the last treatment; 3) Change from Baseline FMA at the 28th natural day after the last treatment
Score of Fugl-Meyer assessment
Simple Test for Evaluating Hand Function (STEF)
时间窗: 1) Before treatment (Baseline); 2) Change from Baseline STEF at the 1st workday after the last treatment; 3) Change from Baseline STEF at the 28th natural day after the last treatment
Score of Simple Test for Evaluating Hand Function
次要结局
- National Institute of Health Stroke Scale (NIHSS)(1) Before treatment (Baseline); 2) Change from Baseline NIHSS at the 1st workday after the last treatment; 3) Change from Baseline NIHSS at the 28th natural day after the last treatment)
研究者
ZHUANG Li, MD
Chief Physician
Beijing Hospital