Current Steering to Optimize Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 11
- 主要终点
- Therapeutic Window
研究概览
简要总结
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.
详细描述
The study is a prospective, multi-center, double-blind, randomized controlled trial.
This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
- •UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
- •DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
- •Medical and mental fitness to comply with programming visit and study related procedures.
- •Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- •Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.
排除标准
- •Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
- •Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.
结局指标
主要结局
Therapeutic Window
时间窗: Day 1 programming visit
The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.
Unified Parkinson's Disease Rating Scale III
时间窗: Day 1 programming visit
The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings. The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108.
次要结局
- Side Effect Thresholds - Single Contact vs. Steering(Day 1 programming visit)
- Finger Tapping Amplitude - Single Contact vs. Steering(Day 1 programming visit)
- Resting Tremor Severity - Single Contact vs. Steering(Day 1 programming visit)