A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS
研究概览
简要总结
This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purpose of this study is to determine if TOPS DBS can improve Parkinson's symptoms compared to Standard DBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and Outcomes Assessor blinded to DBS pattern in use
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
- •Diagnosed with Parkinson's disease
- •Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's disease at least 6 months prior to the study date
- •Responds to DBS by having demonstrated a minimum improvement in motor score
排除标准
- •Score of <24 on the Mini Mental Status Exam
- •Abuses drugs or alcohol
- •History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other neurological disorders (i.e. epilepsy, stroke)
- •Prisoners, employees that report to investigators
结局指标
主要结局
Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS
时间窗: After 1 week treatment period using each pattern
Average difference between the best TOPS and Standard. The MDS-UPDRS Part III is the sum of 33 scores evaluating a set of Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicates no symptom is present and a maximum score of 4 indicates the most severe symptom. The total scale range is 0-132, where higher scores indicate more severe symptoms.
Study related adverse device effects
时间窗: After 1 week treatment period using Standard
Reported AEs
次要结局
- Parkinson's Medication Use(During 1 week treatment period using each pattern)
- Patient Global Impression of Improvement Rating(After 1 week treatment period using each pattern)
- Home Use "On Time"(During 1 week treatment period using each pattern)
- Rest Tremor - Off medication/On DBS(After 1 week treatment period using each pattern)
- Type and severity of side effects of stimulation(During 1 week treatment period using each pattern)
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS(After 1 week treatment period using each pattern)
- Postural Tremor - Off medication/On DBS(After 1 week treatment period using each pattern)
- Bradykinesia - Off medication/On DBS(After 1 week treatment period using each pattern)
- Clinical Global Impression of Improvement Rating(After 1 week treatment period using each pattern)
- Test Pattern Use Count(After 1 week treatment period using each pattern)