Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients With Parkinson' Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- UPDRS-III
研究概览
简要总结
Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 14 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, EEG analysis, and video analysis.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
- •a stable dosage of L-DOPA medications for at least one month;
- •no contraindications for MRI.
排除标准
- •History of stroke or seizures, dementia; previous surgical interventions for Parkinson's disease; contraindications for TMS (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.
研究组 & 干预措施
Sham stimulation followed by Verum stimulation
干预措施: transcranial MR-guided focused ultrasound (Device)
Verum stimulation followed by Sham stimulation
干预措施: transcranial MR-guided focused ultrasound (Device)
结局指标
主要结局
UPDRS-III
时间窗: Beginning and end of each experimental session
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III. 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 scalp EEG(From baseline (pre-sonication) to 10 minutes post-sonication)
研究者
Zhengguo Liu
Department of Neurology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine