Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- the change of freezing of gait questionnaire (FOGQ)
研究概览
简要总结
Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit, especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD patients. In the present randomized controlled trial (RCT) study, the invastigators aim to investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the effects of rTMS over different brain regions will be compared for choosing a better target. The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease with freezing of gait (PD-FOG).
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria
- •Hoehn & Yahr (H-Y) stage was 2 or 3
- •All subjects had freezing of gait which was identified by FOGQ
排除标准
- •cognitive impairment (MMSE score<22) or major depression (HAMD-24 score>25)
- •severe visual and/or haring impairment
- •significant medical or psychiatric illnesses
- •history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients
- •current treatment with medication cannot be maintained during the study
结局指标
主要结局
the change of freezing of gait questionnaire (FOGQ)
时间窗: through study completion, an average of 2 weeks
a self-assessment scale for evaluating FOG severity，the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.
次要结局
- the change of freezing of gait score (FOG score)(through study completion, an average of 2 weeks)
- the change of Parkinson's Disease Questionnaire (PDQ-39)(through study completion, an average of 2 weeks)
- functional image of the brain (FMRI)(through study completion, an average of 10 days)
- the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III(through study completion, an average of 2 weeks)
- the change of Hamilton Depression (HAMD) Scale(through study completion, an average of 2 weeks)
- the change of Mini-mental State Examination (MMSE) scale(through study completion, an average of 2 weeks)