The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changes of Freezing of Gait severity
研究概览
简要总结
This study is a double-blinded randomized study examining the efficacy of the double-site (M1+SMA) repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.
详细描述
Patients in the double-site group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the single-site group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the sham group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 40-80 years;
- •diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria;
- •patients were stable on dopaminergic treatment for at least 3 months;
- •Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1;
- •Patients experienced FOG during an interview.
排除标准
- •comorbidities of major neurologic diseases other than PD;
- •suffer from musculoskeletal disorders that could have interfered with their ability to walk;
- •presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI);
- •marked tremor interfered with TMS detection;
- •previously receiving any kinds of TMS interventions;
- •severe cognitive impairment making cooperation impossible [Mini Mental State Examination (MMSE) < 24];
- •were unable to walk independently during the OFF state.
结局指标
主要结局
Changes of Freezing of Gait severity
时间窗: Assessed at baseline, one day post intervention, one month post intervention
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the FOGQ are 0 and 24. A higher score means a worse outcome. The differences in FOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment.
次要结局
- Changes of Gait speed(Assessed at baseline, one day post intervention, one month post intervention)
- Freezing of Gait severity assessment(Assessed at baseline, one day post intervention, one month post intervention)
- Changes of Stride length(Assessed at baseline, one day post intervention, one month post intervention)
- Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III)(Assessed at baseline, one day post intervention, one month post intervention)
- Changes in brain structure(Assessed at baseline, one day post intervention)
- Changes in functional connectivity in the brain cortex(Assessed at baseline, one day post intervention)
- Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF)(Assessed at baseline, one day post intervention)