Role of Continuous Theta Burst Stimulation as Potential Biomarker of Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Alterations of synaptic depotentiation in primary motor cortex
研究概览
简要总结
The primary endpoint of the study is to identify a neurophysiological biomarker (absence of synaptic depotentiation at primary motor cortex , measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of neurophysiological cTBS depotentiation protocol) as predictor of the development of Levodopa-induced dyskinesia in patients with Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
- •age between 30 and 80 years;
- •ongoing therapy with levodopa;
- •fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire.
排除标准
- •patients unable to give informed consent;
- •cognitive impairment (MMSE ≤ 24);
- •history of epilepsy;
- •pregnant women.
结局指标
主要结局
Alterations of synaptic depotentiation in primary motor cortex
时间窗: 3 years
Alterations of synaptic depotentiation in primary motor cortex will be measured as change in the amplitude of motor evoked potentials recorded at the dorsal first interosseus muscle after administration of depotentiation protocol of continuous theta burst stimulation. Alterations of synaptic depotentiation at the baseline evaluation will be compared between patients who will develop and patients who will not develop dyskinesias (assessed by Unified Dyskinesia Rating Scale part III, range 0-112) during the follow-up.
次要结局
未报告次要终点