Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.
研究概览
简要总结
Patients undergoing Deep Brain Stimulation for Parkinson's disease will be subjected to standard of care programming and compared with the algorithm based programming (StimSearch). Various parameters including the effectivity and efficiency of algorithm programming will be compared against the standard of care programming.
详细描述
Patients of Parkinson's disease undergoing bilateral subthalamic nucleus stimulation (STN), we have already been adequately programmed and have achieved good outcome, will undergo an exploratory study to evaluate the effectiveness of algorithm based programming (Phase 1). Subsequently, patients undergoing STN DBS will be randomly allocated to algorithm based programming/ standard of care programming and after adequate stabilisation evaluated for motor improvement. They will be switched over to the alternative technique of programming and evaluated again after a similar period. Data regarding the time consumed, effectivity and several secondary endpoints will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of bilateral idiopathic Parkinson's disease
- •Exhibit a UPDRS subset III score of ≥ 25 while in the preoperative medication off state
- •Demonstrate an improvement of Parkinson's disease symptoms by ≥30% in the medication off state following a pre-operative levodopa challenge, as assessed by the UPDRS subset III score
- •Possess the ability to comprehend the study's demands, treatment protocols, and procedures, and provide written informed consent before undergoing any study-specific tests or procedures
排除标准
- •Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.
结局指标
主要结局
Comparison of efficacy between StimSearchTM-based programming and the best Standard of Care (SOC) based programming.
时间窗: 4 weeks
Unified Parkinson's disease rating scale scores (part III) will be used to evaluate this. Range (0-132) The lower the score indicates lesser severity of the disease and improved outcome.
Comparison of time required between StimSearch and SOC programming
时间窗: 4 weeks
Total time in minutes will recorded
次要结局
- Comparison of volume of tissue activated (VTA) between StimSearch and SOC(4 weeks)
- Comparison of target volume between StimSearch and SOC(4 weeks)
研究者
Paresh doshi
Director of Neurosurgery and Stereotactic and Functional Neurosurgical program
Jaslok Hospital and Research Centre