Flexible vs. Standard Programming in Parkinson's Disease Patients Receiving Subthalamic Implant: a Double-blind Cross-over Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Change of Overall Global functioning (PGIC)
研究概览
简要总结
Exploring the benefits of the linear lead in deep brain stimulation.
详细描述
Detailed Description:
This is a single-centre, double-blinded cross-over study comparing the 4 contact vs 8 contact electrodes of deep brain stimulation (DBS) patients.
The study will follow 2 phases.
Phase 1:
Visit 1 Screening/Baseline (T0):
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
- Double (Participant, Investigator)
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
- •Patients with a diagnosis of PD according to the British Parkinson's Disease Society
- •Brain Bank criteria (Hughes, Daniel, Kilford, & Lees, 1992), who fulfilled the inclusion and exclusion criteria proposed by the core assessment programme for surgical interventional therapies in PD panel (Defer, Widner, Marié, Rémy, & Levivier, 1999)
- •Male and female patients with idiopathic PD, who have symptoms responsive to L-dopa medications, but who have significant impairment related to PD that is no longer well controlled with pharmacotherapy (i.e., refractory to optimized medical therapy)
- •Patients considered as STN-DBS candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
- •Quality of life and social functioning influenced by levodopa-responsive signs
- •No major comorbidities
排除标准
- •Exclusion criteria will include patients with other significant neurologic or psychiatric illnesses or cognitive deficit.
研究组 & 干预措施
Standard Stimulation
Standard stimulation using contact 3-6 to achieve best therapeutic stimulation
干预措施: Deep brain stimulation (Device)
Flexible stimulation
Flexible stimulation using all available stimulation strategies provided by the VerciseTM system including stimulation of contacts 1-8 and variable pulse width and frequency.
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Change of Overall Global functioning (PGIC)
时间窗: After 3 months of each intervention
The PGIC evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status relative to baseline. This is a seven point scale with lower values indicating worsening and higher values, improvement.
次要结局
- Clinical change in motor symptoms using Unified Parkinson Disease Rating Scale I-IV(After 3 months of each intervention)
- Measure of Quality of life (PDQ-39)(After 3 months of each intervention)
- Number of falls(After 3 months of each intervention)
- Walking speed measure using Prokinetics gait analysis/Zeno Walkway(After 3 months of each intervention)
- Clinical change in motor symptoms(After 3 months of each intervention)
- Double support time measured using Prokinetics gait analysis/Zeno Walkway(After 3 months of each intervention)
- Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI)(After 3 months of each intervention)
- Cadence measured using Prokinetics gait analysis/Zeno Walkway(After 3 months of each intervention)
- Step length measured using Prokinetics gait analysis/Zeno Walkway(After 3 months of each intervention)
研究者
Alfonso Fasano
Professor
University of Toronto