NCT06840678招募中1 期
Patogénesis Cortical De La Enfermedad De Parkinson: Efectos Corticales Y Corticoestriatales De La Estimulación Transcraneal Por Campo Magnético Estático En Pacientes Con Enfermedad De Parkinson
Fundación de investigación HM2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse events (safety)
研究概览
简要总结
This is a pilot open study to test the hypothesis that home-based transcranial static magnetic field stimulation (tSMS) of the supplementary motor area is safe and feasible to modulate corticostriatal activity 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
- Treatment
- 盲法
- None
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
- •idiopathic Parkinson's disease (Brain Bank criteria)
- •optimal clinical response to dopaminergic medication (>30% MDS-UPDRS-III improvement)
排除标准
- •MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
- •presence of levodopa-induced dyskinesias
- •other main neuropsychiatric co-morbidity
结局指标
主要结局
Adverse events (safety)
时间窗: From the start to 3 months after the end of treatment (5 months)
Number of device-related AE
Feasibility of home-based tSMS
时间窗: From the start to the end of treatment (8 weeks)
Number of home-based tSMS sessions completed, according to patient's diaries
次要结局
- Sleep improvement(Within one week after the end of treatment compared to baseline)
- Subjective improvement(Within one week after the end of treatment compared to baseline)
- Motor improvement(Within one week after the end of treatment compared to baseline)
研究者
Guglielmo Foffani
PhD
Fundación de investigación HM
研究点 (2)
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