NCT05752240招募中不适用
Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年3月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Reduction of dyskinesia
研究概览
简要总结
The main objective of the study is to evaluate the efficacy of 10 sessions of transcranial direct current stimulation of the primary motor cortex to reduce levodopa-induced dyskinesia
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
- Single (Investigator)
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 and levodopa-induced dyskinesia;
- •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
Reduction of dyskinesia
时间窗: 15 days
Change in the total score of part III of the Unified Dyskinesia Rating Scale (range 0-112, 112 is the worse outcome) in on motor state at the assessment made three days after the end of treatment compared with the assessment made at baseline in the groups of patients treated with tDCS and sham-stimulation, respectively
次要结局
未报告次要终点
研究者
研究点 (2)
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