Simpler and Safer Deep Brain Stimulation for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in motor function.
研究概览
简要总结
The aim is to improve availability and acceptability of deep brain stimulation (DBS) for the treatment of Parkinson by shortening and simplifying the implantation procedure, thereby reducing time in surgery, complexity, post-surgery complications and cost, and increasing patient satisfaction.
To facilitate the shortening and simplifying of the implantation procedure, a miniaturised skull-mounted DBS device (Picostim) has been developed which is optimised to generate waveforms needed for stimulation of the subthalamic nucleus (STN) and STN region, employing a unique method of controlling stimulation current. The planned study is a single centre, open label, non-randomised design with the primary objective of showing similarity in control of motor symptoms for the Picostim device compared with previously published data for existing DBS devices.
详细描述
High-frequency DBS of the STN and STN region is an established treatment for moderate to advanced Parkinson with motor fluctuations, reducing motor symptoms in late stage levodopa responsive patients, who are not adequately controlled by optimal medical therapy alone. However, DBS is presently employed in less than 2% of Parkinson patients. Although a proportion of Parkinson patients are for various reasons not suitable for DBS, currently there is a significant under-utilisation of this approach and in part this is due to perceived surgical risk. Other limitations to adoption are availability of surgeons and infrastructure, particularly outside the USA, and expense.
The objective of this project is to collect and assess safety data for a new DBS device for treatment of Parkinson and validate a new surgical technique employing a skull mounted device. The device, called Picostim, is highly miniaturised and optimised for Parkinson, with current controlled outputs and a rechargeable battery. In typical use, an inductive recharge is required once per week for one hour and service-life is projected to be 17 years. This project aims to advance the technology of DBS so that it is possible to treat a greater proportion of patients more easily, by shortening and simplifying procedures thereby reducing surgical time, complexity and cost, while increasing patient satisfaction and quality of life. Up to 25 patients will receive the Picostim implantation and will be followed up over a one-year period.
This pilot study will be sufficient to make an application for a CE mark in Europe and should inform future studies that are envisaged to be required to prepare an FDA pre-market application.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in motor function.
时间窗: 26 weeks
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) III score at 26 weeks post implantation with stimulation on without medication compared with baseline assessment (without medication). Standard range is from 0 to 108, lower score is better than higher score
Collection and recording of adverse events
时间窗: 26 weeks
Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events
次要结局
- Motor functions assessed through recording of motor fluctuation diary(12, 26 and 52 weeks post device implantation.)
- Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description)(12, 26 and 52 weeks post device implantation.)
- Post-operation complications: % of patients with infections and pain at the implantation site(12 weeks)
- Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description)(12, 26 and 52 weeks post device implantation.)
- Surgical time to complete procedure(12, 26 and 52 weeks intra-operative post device implantation.)
- Motor examinations assessed through standard UPDRS Test (see description)(12, 26 and 52 weeks post device implantation.)
- Quality of life assessed through standard Eq5D questionnaire (see description)(12, 26 and 52 weeks post device implantation.)
- Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire(12, 26 and 52 weeks post device implantation.)
- Motor and cognitive functions(12, 26 and 52 weeks post device implantation.)
- Cognitive functions assessed through standard Beck Depression Inventory Test (see description)(12, 26 and 52 weeks post device implantation.)
- Activities in Daily Living assessed through standard UPDRS Test (see description)(12, 26 and 52 weeks post device implantation.)
- Complications of Therapy assessed through standard UPDRS Test (see description)(12, 26 and 52 weeks post device implantation.)
- Safety data assessed through analysis of adverse events occurence(12, 26 and 52 weeks post device implantation.)
- Non-Motor functions assessed through standard Dementia Rating Scale (see description)(12, 26 and 52 weeks post device implantation.)