A Randomized, Controlled, Patient- and Assessor- Blinded, Exploratory Clinical Trial to Search the Stimulation Site for Repetitive Transcranial Magnetic Stimulation (rTMS) That Improves Upper Extremity Function After Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change of Fugl-Meyer Assessment
研究概览
简要总结
A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.
详细描述
Some studies related to rTMS for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. It is known that function is restored through various neurophysiological changes.
However, there are not many studies on rTMS in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment.
Recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fMRI (Functional Magnetic Resonance Imaging) are being used in various fields.
Based on the idea in this regard, recent studies have been conducted that the effect of rTMS treatment is better than the existing method when fMRI is used to identify the brain regions involved in the movement of the upper and lower extremities.
The purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fMRI and rTMS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults over 20 years of age
- •Patients 3 months or more after stroke onset
- •Patients with NIHSS score of 1 or more to 20 or less
- •After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate and agrees in writing to abide by the precautions
排除标准
- •Patients who fall under one or more of the following conditions are not eligible to participate in the study.
- •Patients with systemic infectious disease at the time of participation in the clinical trial
- •In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
- •Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
- •Other cases where the researcher determines that participation in this clinical trial is not appropriate
- •Those who are contraindicated in repetitive transcranial magnetic stimulation A. When metal materials (deep brain stimulation electrode, brain aneurysm clip, cardiac pacemaker, etc.) are in the body B. Uncontrolled epilepsy (epilepsy), patients with psychiatric disorders
- •Pregnant, lactating women and patients with potential for pregnancy
- •Patients with contraindications for imaging tests
- •Those who have undergone cerebral surgery due to past or current related medical history
研究组 & 干预措施
Sham group
Sham group: shame rTMS( sound mode) is applied over the M1 cortex of the injured hemisphere which is the site that caused the largest visible twitch in the participant's thumb when stimulation is applied
干预措施: Sham (Device)
rTMS over the M1 cortex of the injured hemisphere localized by motor action potential
Experimental A group : rTMS was administered by trained physicians over the M1 cortex of the injured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb.
干预措施: rTMS (Device)
rTMS over the specific site of the injured hemisphere localized by fMRI
Experimental B group : rTMS was administered by trained physicians over the specific site which is after checking the brain site activated during finger tapping during fMRI imaging, target coordinates are set based on the 10-20 EEG system coordinate system in the taken MRI image.
干预措施: rTMS (Device)
结局指标
主要结局
Change of Fugl-Meyer Assessment
时间窗: Baseline - 1month - 3months
The difference in the FMA (Fugl-Meyer Assessment) between the three groups at baseline, 30 days and 90 days was confirmed by comparing differences.\[0\~66 for each arm\] (The higher values represent a better outcome.)
次要结局
- Change of Manual muscle Test(Baseline - 1month - 3months)
- Change of Clinical Dementia Rating(Baseline - 1month - 3months)
- Change of Range of motion(Baseline - 1month - 3months)
- Change of Functional Ambulation Category(Baseline - 1month - 3months)
- Change of Berg Balance Scale(Baseline - 1month - 3months)
- Change of Jebsen taylor hand function test(Baseline - 1month - 3months)
- Change of Geriatric Depression Scale(Baseline - 1month - 3months)
- Change of Electroencephalography(Baseline - 1month - 3months)
- Changes in test results of WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL)(Baseline - 1month - 3months)
- Change of Time up and go(Baseline - 1month - 3months)
- Change of Action reach arm test(Baseline - 1month - 3months)
- Change of Evoked Potential(Baseline - 1month - 3months)
- Change of Modified Barthel index(Baseline - 1month - 3months)
- Change of Korean Mini Mental State Exam(Baseline - 1month - 3months)
- Changes in test results of AST(IU/L), ALT(IU/L)(Baseline - 1month - 3months)
- Change of Motor Assessment Scale(Baseline - 1month - 3months)
- Change of Trunk Imbalance Scale(Baseline - 1month - 3months)
- Change of Functional Independence Measure(Baseline - 1month - 3months)
- Change of National Institutes of Health Stroke Scale(Baseline - 1month - 3months)
- Change of Global Deterioration Scale(Baseline - 1month - 3months)
- Change of Brain imaging(Baseline - 1month - 3months)
- Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL)(Baseline - 1month - 3months)
- Change of Motricity index(Baseline - 1month - 3months)
研究者
MinYoung Kim, MD, PhD
Professor of CHA university, M.D., Ph.D.
Bundang CHA Hospital