Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
研究概览
简要总结
The posterior subthalamic area holds promise as a target region for deep brain stimulation in tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide tube surgical technique, subregions of the posterior subthalamic area can be individually targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona incerta may provide improved control of movement disorder symptoms than the more commonly stimulated dorsal zona incerta.
详细描述
Randomisation between two treatment locations each programmed up to 3 milliamps in amplitude for 3 months: (1) caudal zona incerta and (2) dorsal zona incerta. This 6-month-long randomised phase is followed by 6 months of unblinded individualised empirically optimised settings programmed by a neurologist. Each of the three treatment periods ends with a full clinical, functional and quality of life assessment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medication-refractory tremor and/or Parkinson's disease as defined by UK Brain Bank criteria with either inadequate control of motor fluctuations or dyskinesia despite optimised medical therapy
排除标准
- •Significant cognitive, psychiatric and medical co-morbidities
- •Dementia with mini mental state examination score of less than 25/30
- •Limited life expectancy due to a co-morbid condition
研究组 & 干预措施
Dorsal zona incerta
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
干预措施: Up to 3 mA, 60 us, 130 Hz deep brain stimulation (Device)
Caudal zona incerta
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
干预措施: Up to 3 mA, 60 us, 130 Hz deep brain stimulation (Device)
Empirical deep brain stimulation
Empirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome.
干预措施: Empirical unblinded deep brain stimulation programming (Device)
结局指标
主要结局
Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
时间窗: 6 months
At end of second randomised crossover trial period
Change from baseline Fahn Tolosa Marin tremor scale at 12 months
时间窗: 12 months
At end of empirical deep brain stimulator programming period for tremor patients
Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months
时间窗: 3 months
At end of first randomised crossover trial period
Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months
时间窗: 12 months
At end of non-randomised empirical deep brain stimulator programming period
Change from baseline Fahn Tolosa Marin tremor scale at 3 months
时间窗: 3 months
At end of first randomised crossover trial period for tremor patients
Change from baseline Fahn Tolosa Marin tremor scale at 6 months
时间窗: 6 months
At end of second randomised crossover trial period for tremor patients
次要结局
- Change from baseline Short form 36 at 3 months(3 months)
- Change from baseline ON-OFF diary at 3 months(3 months)
- Change from baseline Short form 36 at 6 months(6 months)
- Change from baseline L-dopa equivalent dose at 6 months(3 months)
- Change from baseline neuropsychological battery at 3 months(3 months)
- Change from baseline neuropsychological battery at 6 months(6 months)
- Change from baseline verbal fluency at 3 months(3 months)
- Change from baseline verbal fluency at 12 months(12 months)
- Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months(3 months)
- Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months(3 months)
- Change from baseline Abnormal Involuntary Movement Scale at 6 months(6 months)
- Change from baseline ON-OFF diary at 12 months(12 months)
- Adverse events(12 months)
- Change from baseline Parkinsons Disease Quality of Life 39 at 3 months(3 months)
- Change from baseline L-dopa equivalent dose at 12 months(12 months)
- Change from baseline ON-OFF diary at 6 months(6 months)
- Change from baseline Parkinsons Disease Quality of Life 39 at 6 months(6 months)
- Change from baseline Parkinsons Disease Quality of Life 39 at 12 months(12 months)
- Change from baseline neuropsychological battery at 12 months(12 months)
- Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months(6 months)
- Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months(12 months)
- Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months(12 months)
- Change from baseline Short form 36 at 12 months(12 months)
- Change from baseline L-dopa equivalent dose at 3 months(3 months)
- Change from baseline verbal fluency at 6 months(6 months)
- Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months(6 months)
- Change from baseline Abnormal Involuntary Movement Scale at 12 months(12 months)
- Change from baseline Abnormal Involuntary Movement Scale at 3 months(3 months)
研究者
Professor Christopher Lind
Professor, School of Surgery
The University of Western Australia