Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Laboratory gait analysis after 8 courses of iTBS
研究概览
简要总结
The gait symptoms are usually refractory to the dopaminergic agents and some other resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for in this regard. To study the impact of rTMS, investigators will adopt a domestically developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the electroencephalographic and electromyographic signals for PD patients when walking in the gait laboratory or when conducting leg dorsiflexion movement on sitting.
详细描述
The Bereitschaftspotential (BP), event related synchronization (ERS) and event related dysynchronization (ERD) will be analyzed for the investigation of the possible differences of brain activities prior to leg voluntary movement between patients and controls. In addition, the synchronized recorded gait parameters for gait ignition,turning and termination will also be analyzed. The information gathered will allow us to further understand the pathophysiology of the gait freezing in PD. Investigators will deliver a course of rTMS with intermittent theta burst paradigm of the leg motor cortex to investigate whether the non-invasive brain stimulation can ameliorate the gait freezing in PD patients. The subjects will be assessed before and 4 times after rTMS during an 8-week period with clinical scoring batteries and electrophysiological recording as aforementioned. At the end of the 8th week, the test group and sham group will cross over and undergo the same procedures as aforementioned. The serial comprehensive investigations in this project will not only promote our understanding of the gait freezing pathophysiology but also may charge a novel trail for the management of long suffering symptom of the PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PD will be diagnosed according to the Brain Bank criteria.
排除标准
- •Patients had past history of epilepsy, intracranial operation or brain tumor.
- •Hoehn & Yahr Stage V.
结局指标
主要结局
Change in Laboratory gait analysis after 8 courses of iTBS
时间窗: baseline to week 8
Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.
次要结局
- Change in Tinetti's Mobility Index after 8 courses of iTBS(baseline to week 8)
- Change in new freezing of gait questionnaire (FOG-Q) after 8 courses(baseline to week 8)
- Change in Clinical Global Impressions (CGI) after 8 courses of iTBS(baseline to week 8)
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS(baseline to week 8)
- Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS(baseline to week 8)
- Change in Fall assessment test after 8 courses(baseline to week 8)
- Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS(baseline to week 8)
研究者
Chon-Haw Tsai
The chief, Department of Neurology
China Medical University Hospital