Subthalamic Steering for Therapy Optimization in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Muscle Rigidity
研究概览
简要总结
Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus [STN_O] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact [STN_D].
详细描述
Twenty PD patients will be enrolled in this cross-over double-blind RCT to evaluate both the safety and efficacy of directional STN stimulation [STN_D] compared with standard omnidirectional STN stimulation [STN_O]. The primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface EMG recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (Levin et al., 2009) assessed 6 months after implantation in cross-over design. The trial is designed to detect with an 80% power a change of 0.27 mA of the therapeutic stimulation threshold with two-tailed P < 0.05 (Wilcoxon rank sum test). Secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. Visits are scheduled at weeks 1 (V1), 6 (V2), 24 (V3), 27 (V4), and 30 (V5) from baseline (V0).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Written informed consent
- •Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms
排除标准
- •Cognitive impairment (Mini Mental State Exam < 20)
- •Suicidality, Psychosis
- •Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
- •Pregnancy
研究组 & 干预措施
STN_O
Omnidirectional Deep Brain Stimulation of STN
干预措施: Omnidirectional Deep Brain Stimulation of STN (Device)
STN_D
Directional Deep Brain Stimulation of STN
干预措施: Directional Deep Brain Stimulation of STN (Device)
结局指标
主要结局
Muscle Rigidity
时间窗: 6 months post-operatively
Surface-Electromyography (EMG) of M. biceps brachii and M. triceps brachii
次要结局
- Clinical motor and non-motor symptoms (8)(6 months post-operatively)
- Freezing of gait (2)(6 months post-operatively)
- Clinical motor and non-motor symptoms (2)(6 months post-operatively)
- Neurocognitive and non-motor symptoms (3)(6 months post-operatively)
- Clinical motor and non-motor symptoms (1)(6 months post-operatively)
- Clinical motor and non-motor symptoms (3)(6 months post-operatively)
- Clinical motor and non-motor symptoms (4)(6 months post-operatively)
- Clinical motor and non-motor symptoms (5)(6 months post-operatively)
- Clinical motor and non-motor symptoms (6)(6 months post-operatively)
- Clinical motor and non-motor symptoms (7)(6 months post-operatively)
- Neurocognitive and non-motor symptoms (1)(6 months post-operatively)
- Neurocognitive and non-motor symptoms (2)(6 months post-operatively)
- Neurocognitive and non-motor symptoms (4)(6 months post-operatively)
- Neurocognitive and non-motor symptoms (5)(6 months post-operatively)
- Neurocognitive and non-motor symptoms (6)(6 months post-operatively)
- Neurocognitive and non-motor symptoms (7)(6 months post-operatively)
- Neuropsychiatric symptoms (1)(6 months post-operatively)
- Neuropsychiatric symptoms (2)(6 months post-operatively)
- Freezing of gait (1)(6 months post-operatively)
- Quality of Life(6 months post-operatively)
研究者
Alireza Gharabaghi, MD
Professor
University Hospital Tuebingen