Exploratory Study to Evaluate the Effective Site for Control of Motor Coordination Function After Transcranial Direct Current Stimulation in Multiple Systemic Atrophy With Cerebellar Feature
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from International Cooperative Ataxia Rating Scale (ICARS)
研究概览
简要总结
The aim of study is to investigate most effective site for control the motor coordination using transcranial direct current stimulation in multiple system atrophy with cerebellar feature
详细描述
Participants receive transcranial direct current stimulation (tDCS) over M1, cerebellar cortex or sham stimulation for 30 minutes. The type of stimulation depends on random assignment. The participants have a 1 week of wash out period between each stimulation.
The assessment will be done by International Cooperative Ataxia Rating Scale (ICARS), GAITRITE (CIR Systems Inc., Clifton, New Jersey, USA) and PEDOSCAN (DIERS PEDO, Germany) at baseline and immediately after each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the clinical criteria for probable multiple system atrophy with cerebellar features (MDS second consensus statement on the diagnosis of multiple system atrophy)
- •Patients aged between 40 and 70
- •Patients who do not have rigidity and bradykinesia
- •Patients who have given voluntary consent after understanding the content of the clinical trial
排除标准
- •Patients with a serious cognitive disorder, behavioral disorder, or mental illness
- •Patients have history of seizure, stroke, encephalitis, other degenerative neurological disease
- •Patients with a serious medical disease
- •Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease
- •Patients with un-controlled high blood pressure or diabetes
- •Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
研究组 & 干预措施
tDCS (M1)
The participants will be submit to tDCS applied over the motor cortex (M1)
干预措施: transcranial direct current stimulation (Device)
tDCS (Cerebellar cortex)
The participants will be submit to tDCS applied over the cerebellar cortex
干预措施: transcranial direct current stimulation (Device)
Sham stimulation
The participants will be submit to sham stimulation
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Change from International Cooperative Ataxia Rating Scale (ICARS)
时间窗: per session: at baseline and within 30 minutes tDCS treatment completion
The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders. Higher scores indicate higher levels of impairment.
次要结局
- Change from posturography(per session: at baseline and within 30 minutes tDCS treatment completion)
- Change from temporospatial parameters of gait(per session: at baseline and within 30 minutes tDCS treatment completion)
研究者
Jinyoung Youn
Associate Professor
Samsung Medical Center