Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment.
研究概览
简要总结
This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will receive real tSMS treatment, the other half will receive sham treatment (placebo).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced idiopathic Parkinson's disease (Brain Bank criteria)
- •optimal clinical response to dopaminergic medication (>30% UPDRS-III improvement)
- •presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one upper limb
排除标准
- •MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
- •other main neuropsychiatric co-morbidity
研究组 & 干预措施
tSMS
30 min of tSMS, one session per day, for 9 days over 2 weeks
干预措施: tSMS (Device)
sham
30 min of sham, one session per day, for 9 days over 2 weeks
干预措施: sham (Device)
结局指标
主要结局
Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment.
时间窗: One day after the end of treatment compared to baseline
次要结局
- Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one week after the end of treatment.(One week after the end of treatment compared to baseline)
- Dyskinesia severity evaluated for each body segment(Baseline, one day and one week after the end of treatment)
- Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC)(One day and one week after the end of treatment)
- Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale(Baseline, one day and one week after the end of treatment)
研究者
Guglielmo Foffani
Principal Investigator
Fundación de investigación HM