Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads: a Double-blind Cross-over Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number/incidence of adverse events
研究概览
简要总结
Exploring directional lead
详细描述
This is a single-centre, double-blinded cross-over study comparing the standard electrode configuration (ring-mode) vs. directional electrode configuration for steered stimulation of deep brain stimulation (DBS) patients.
The study will follow 2 phases.
Phase 1:
Visit 1 Screening/Baseline (T0):
As per current standard care for patients undergoing subthalamic deep brain stimulation (STN-DBS), participants will be screened 3-6 months before the DBS STN implant surgery (T0) according to the inclusion/exclusion criteria.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard Stimulation
Participants will receive stimulation using the best contact combination in ring mode.
干预措施: Deep brain stimulation (Device)
Directional Stimulation
Participants will receive stimulation using the best segmented (steered) contacts.
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Number/incidence of adverse events
时间窗: Throughout the study, averaging 6 months
Number/incidence of adverse events
次要结局
- Double support time measured with the Zeno Walkway(After 3 months of each intervention)
- Change from baseline in a measure of health related quality of life and non-motor symptoms of Parkinson's disease using the Parkinson's disease Questionnaire (PDQ-39)(After 3 months of each intervention)
- Change in the Movement Disorders sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS), a measure of various motor and non-motor symptoms used to assess the clinical course of Parkinson's longitudinally.(After 3 months of each intervention)
- Percentage of ON time without troublesome dyskinesias during waking hours(After 3 months of each intervention)
- Change in levodopa equivalent daily dose (LEDD)(After 3 months of each intervention)
- Walking speed measured with the Zeno Walkway(After 3 months of each intervention)
- Measure of resting-state local field potentials and functional connectivity of the brain using magnetoencephalography (MEG)(After 3 months of each intervention)
- Patients Global Impression of Change (PGIC)(After 3 months of each intervention)
- Change in articulation rate of speech using a Phonetics Software(After 3 months of each intervention)
- Change in dysfluency of speech using a Phonetics Software(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)
- Step length measured with the Zeno Walkway(After 3 months of each intervention)
- Cadence measured with the Zeno Walkway(After 3 months of each intervention)
- Number of falls or near-falls(Collected after 3 months of each intervention, but assessing all intervention period, averaging 6 months)
- Change in intelligibility of speech using a Phonetics Software(After 3 months of each intervention)
研究者
Alfonso Fasano
Professor of Neurology
University of Toronto