NCT01750242已完成不适用
OPTIVISE Map Concordance Study in DBS for Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap
研究概览
简要总结
To evaluate DBS device settings and match with the features of the DBS care management software.
详细描述
This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease
- •Patient who has had lead placement in the Subthalamic nucleus
- •Patient with pre-op MRI available
- •Patient with post-op CT scan available showing placement of the lead
- •Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off
排除标准
- •Patient who has had clinically significant persistent stimulation related adverse effects
- •Patient who has evidence of lead migration without lead revision
- •Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)
结局指标
主要结局
To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap
时间窗: 18 months
The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.
次要结局
- Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores(Change from baseline to 18 months)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Nurse Management of Neuromodulation TherapyParkinson'sNCT02177149Medical College of Wisconsin
已完成
不适用
European Deep Brain Stimulation (DBS) Depression StudyDepressive Disorder, MajorNCT01331330Abbott Medical Devices9
已完成
不适用
CUSTOM-DBS: Current Steering to Optimize Deep Brain StimulationParkinson's DiseaseNCT01896115Boston Scientific Corporation40
已完成
不适用
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's DiseaseParkinson DiseaseNCT04547712MedtronicNeuro85
已完成
不适用
Verrification of the holistic BPSD Care System intervation-Electronic versionDementiaJPRN-UMIN000041230Ministry of education6