A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
研究概览
简要总结
A randomized, double-blind, sham-controlled unicenter clinical trial was used to investigate the effectiveness and neural mechanism of high-frequency repetitive transcranial magnetic stimulation in the treatment of upper limb bradykinesia in patients with Parkinson's disease.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hoehn and Yahr (HY) stage 1-2
- •Able to understand and cooperate with the study
- •Predominantly characterized by bradykinesia
- •Onset on the left side
排除标准
- •Contraindications for TMS including DBS surgery, Ventriculoperitoneal shunt, etc
- •Other neurological disorders
- •Significant resting tremor, with MDS-UPDRS-III tremor score ≥3
- •Resting threshold cannot be measured
- •Received other TMS treatments within the last 3 months
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: 2 weeks and 4 weeks
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.
次要结局
- cortical activation detected by fNIRS(2 weeks and 4 weeks)
研究者
Zhengguo Liu
Director of Department of Neurology, Principal Investigator, Clinical Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine