Kombinierte Tiefe Hirnstimulation Des Nucleus Subthalamicus Und Nucleus Basalis Meynert Zur Behandlung Der Parkinson-Krankheit Mit Demenz
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- safety as determined by spontaneously reported adverse events
研究概览
简要总结
Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having mild to moderate dementia.
详细描述
Combined subthalamic and Nucleus basalis Meynert Deep Brain Stimulation for Parkinson's disease with dementia DEMPARK-DBS STUDY
Indication: Parkinson's disease with mild to moderate dementia
Primary Objective: To provide a proof of safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having mild to moderate dementia.
Exploratory Objectives: To determine if additional NBM stimulation improves or slows progression of cognitive decline in patients with advanced Parkinson's disease having mild to moderate dementia
Test Device: Boston Scientific Corporation (BSC) Neuromodulation Vercise™ System. A neurostimulation device consisting of an implantable pulse generator (IPG), integrated rechargeable battery, two DBS leads, a splitter allowing to control four electrodes, surgical tools, and external devices (programming system, remote control, and charging system).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at the time of enrollment: 35 - 75 years.
- •Diagnosis of idiopathic PD with probable Parkinson's disease dementia (PDD) as defined by the MDS consensus guidelines (Emre et al., 2007)
- •Mild to moderately severe dementia as defined by a Mini-Mental State Examination (MMSE) score of 10 to 24
- •Duration of bilateral idiopathic PD: ≥5 years of motor symptoms.
- •Severity of bilateral idiopathic PD in the meds off state: modified Hoehn and Yahr stage ≥
- •UPDRS subset III score of ≥30 in the meds off, stim off state.
- •Levodopa must improve PD symptoms by ≥30% in a levodopa challenge test, as measured by UPDRS subset III score.
- •PDD with a symptom onset at least 2 years after first symptoms of PD
- •Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary) if mentally competent or, if incompetent, their legally authorized representatives.
- •Able to understand the study requirements and the treatment procedures and to provide written informed consent before any study-specific tests or procedures are performed. If mentally incompetent, the legally authorized representative provides written informed consent
排除标准
- •Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
- •Any current drug or alcohol abuse.
- •Any history of recurrent or unprovoked seizures.
- •Any prior movement disorder treatments that involved intracranial surgery or device implantation.
- •A history of neurostimulation intolerance in any area of the body.
- •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.
- •Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- •Pregnancy, breast-feeding, or lack of reliable contraception
结局指标
主要结局
safety as determined by spontaneously reported adverse events
时间窗: 48 weeks
Safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation as determined by spontaneously reported adverse events
次要结局
未报告次要终点