Clinical Investigation for Adaptive Deep Brain Stimulation (aDBS)Closed-loop Device Controlled by Local Field Potentials in Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS
研究概览
简要总结
Despite its therapeutic effectiveness in Parkinson's disease (PD) the current deep brain stimulation (DBS) strategy could achieve an even better clinical result by adapting to patient's condition. As intracerebral activity analyzed by recording local field potentials (LFPs) from DBS electrodes correlates to PD symptoms, a new stimulation approach would be an "intelligent" adaptive DBS system able to change stimulation settings automatically to the patient's needs using LFPs as control variable.
详细描述
Despite their proven efficacy in treating Parkinson's disease (PD), deep brain stimulation (DBS) systems could be further optimized to maximize treatment benefits. In particular, because current DBS strategies based on fixed stimulation settings leave the typical parkinsonian motor fluctuations and rapid symptom variations partly uncontrolled, research has focused on developing a novel adaptive DBS (aDBS) system able to adapt moment-by-moment to the patient's clinical condition. aDBS consists of a simple closed-loop model designed to measure and analyze a control variable reflecting the patient's clinical condition to change stimulation settings and send them to an "intelligent" implanted stimulator.
Intracerebral activity analyzed by recording local field potentials (LFPs) from electrodes implanted for DBS in the past 15 years has helped in clarifying basal ganglia pathophysiology and its relation to PD symptoms. Many LFP studies have revealed unknown functions of basal ganglia in PD patients during the execution of motor, cognitive, and behavioral task showing the existence of a "code" in LFP oscillations corresponding to the of patient's clinical condition. LFP-clinical correlations should provide the rationale for developing and implementing new aDBS devices able to adapt stimulation parameters moment-by-moment to the individual patient's needs using LFPs as a control variable for feedback.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient affected by Parkinson's Disease and implanted with DBS electrodes, following the inclusion criteria of L.I.M.P.E., 2003
排除标准
- 未提供
研究组 & 干预措施
aDBS
The aDBS (adaptive Deep Brain Stimulation) device is applied both in aDBS and in DBS modality, for two hours in random order for two days. The aDBS can be programmed to deliver aDBS controlled by local fields potential or conventional DBS.
干预措施: aDBS (Device)
aDBS
The aDBS (adaptive Deep Brain Stimulation) device is applied both in aDBS and in DBS modality, for two hours in random order for two days. The aDBS can be programmed to deliver aDBS controlled by local fields potential or conventional DBS.
干预措施: DBS (Device)
结局指标
主要结局
Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS
时间窗: up to1 year
Number of participants with adverse events
时间窗: up to 1 year
Counting the number of patient with adverse events (adimensional unit)
次要结局
未报告次要终点