Randomized Controlled Trial Comparing Imaging-based Programming With Threshold-assessment Based Programming of Deep Brain Stimulation for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III in OFF phase
研究概览
简要总结
The goal of this single-center prospective, randomized, open-label clinical trial is to compare the effectiveness of imaging-based DBS programming with threshold assessment-based DBS programming in patients with Parkinson's disease and motor response fluctuations.
The main question the study aims to answer is:
Is the improvement of motor symptoms in the OFF-drug phase following STN DBS for Parkinson's disease, using imaging-based DBS programming only, non-inferior to the improvement of motor symptoms following DBS programming with threshold assessment at six months follow-up?
Participants will be randomized to imaging-based programming or to threshold assessment-based programming. The main clinical outcome is motor symptoms; secondary outcomes are level of physical disability and quality of life, among others.
详细描述
Rationale:
Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) is an established treatment for disabling motor symptoms of Parkinson's disease (PD). Correct programming of DBS settings to provide optimal stimulation within the target region is crucial for a successful clinical outcome. To date, programming DBS settings is based on the selection of contact point(s) and stimulation parameters with standardized threshold assessments: for each contact point the current is increased in small steps and the severity of motor symptoms and possible adverse effects are assessed with each step. This process is challenging and time consuming because of the vast number of possible parameter combinations. Furthermore, individual variation in patient anatomy, placement of DBS leads and the occurrence of adverse effects must be considered. This results in long programming sessions that can be exhausting for patients and often leads to inconclusive results due to fatigue. Imaging techniques have been improved greatly over the years and could be useful for programming of DBS settings based on patient-specific anatomy.
Objective:
The aim of this study is to determine whether imaging-based DBS programming for the treatment of Parkinson's motor symptoms in STN DBS is non-inferior to the current standard practice of clinical threshold assessment-based DBS programming.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients cannot be blinded for the treatment allocation, because the person who programs the DBS receives either dictated stimulation parameters based on imaging or proceeds with care as usual with the threshold assessment. Blinded assessment of the primary outcome will be done by means of a physical examination blinded for randomization arm.
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
- •Parkinson's disease diagnosis based on the clinical diagnostic criteria of Movement Disorder Society
- •Scheduled for DBS screening
- •Age of 18 years or older
- •Understand the Dutch language
排除标准
- •Legally incompetent adults
- •No written informed consent
- •Previous functional stereotactic neurosurgery
- •Current depression or psychosis
结局指标
主要结局
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III in OFF phase
时间窗: Change from baseline to 6 months of DBS.
The MDS-UPDRS III measures severity of Parkinson's disease. The scores range between 0 - 132, higher scores indicating worse motor symptoms.
次要结局
- Final DBS settings(At 6 months of DBS)
- Patient satisfaction of the outcome of treatment(At 6 months of DBS)
- Academic Medical Center Linear Disability Score (ALDS)(Change from baseline to 6 months of DBS.)
- MDS-UPDRS I(Change from baseline to 6 months of DBS.)
- MDS-UPDRS III in ON phase(Change from baseline to 6 months of DBS.)
- Use of care(At 6 months of DBS)
- MDS-UPDRS IV(Change from baseline to 6 months of DBS.)
- MDS-UPDRS II in ON phase(Change from baseline to 6 months of DBS.)
- Parkinson's Disease Questionnaire 39 (PDQ-39)(Change from baseline to 6 months of DBS.)
- Patient evaluation of the burden of therapy(At 6 months of DBS)
- Adverse effects(At 6 months of DBS)
- Total duration of programming sessions(At 6 months of DBS)
研究者
Rob M.A. de Bie
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)