Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes of Timed up and go
研究概览
简要总结
Spinocerebellar ataxia (SCA) is a group of inherited brain disorders. SCA often result in poor limb coordination. This study aims to discover the effects of repeated transcranial magnetic stimulation (rTMS) on balance & gait in SCA. The hypothesis of this study is that rTMS might improve SCA limb functional performance.
详细描述
rTMS has been shown that improves walking speed and balance performance, however, the optimal treatment protocols have not been approved. Past studies used different frequencies 1 Hz, 5 Hz and 10 Hz to improve functional performance. The results might be affected by the types of SCA. In this study, we will focus on the SCA type 3 to assess the effects on high frequency (10 Hz) of rTMS intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCA type 3
- •independently walk with/without an assistive device
- •SARA greater than 3
排除标准
- •Epilepsy history
- •Unstable blood pressure
- •Brain Trauma
- •Alcoholism, drug abuse, antipsychotics drug use
- •Metallic hardware (e.g. - cochlear implants, brain stimulators or electrodes, aneurysm clips) anywhere in head.
- •Dementia, depression
结局指标
主要结局
Changes of Timed up and go
时间窗: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Timed up and go (TUG): Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
Changes of SARA
时间窗: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Scale for the Assessment and Rating of Ataxia (SARA): a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Changes of International Cooperative Ataxia Rating Scale
时间窗: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
International Cooperative Ataxia Rating Scale (ICARS): quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria, and Oculomotor disorders.It translates the symptomatology of cerebellar ataxia into a scoring system out of 100.
Changes of Center of pressure trajectory
时间窗: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Center of pressure (COP): he trajectory of the COP, commonly known as a stabilogram, during static balance is frequently used to measure postural control. When standing still on a force platform, the COP is thought to be an indicator of the motor mechanisms involved in maintaining balance with opened-eyes or closed-eyes. Two trials for each condition were performed within 5 minutes.
Changes of Electromyography of Gait
时间窗: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway.
Changes of Berg Balance Scale
时间窗: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
Berg Balance Scale (BBS): a widely used assessment to determine a person's balance abilities. The test contains 14 simple tasks, scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. The entire process takes about 20 minutes to complete.
Changes of Kinematic of Gait
时间窗: Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2),
The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway.
次要结局
- Changes of Mini-mental state examination(Baseline (T0))
- Concentration of Neurofilament(Baseline (T0), 12 days after first rTMS intervention (T2))
研究者
Sen-yung Liu
Chief Medical Officer
Changhua Christian Hospital