Simultaneous Deep Brain Stimulation of the Globus Pallidus Internus and the Nucleus Basalis of Meynert in Patients With Parkinson's Disease and Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease with mild cognitive impairment as determined by reported adverse events.
研究概览
简要总结
Phase 1 study evaluating the safety of combined bilateral globus pallidus internus (GPi) and nucleus basalis of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction, respectively, in patients with moderate to advanced Parkinson's disease having mild cognitive impairment.
详细描述
This study aims to provide a proof of safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease having mild cognitive impairment.
GPi stimulation with high-frequency ameliorates the cardinal motor symptoms and motor complications in Parkinson's disease patients, and this present study also wants to determine if additional NBM stimulation, with low-frequency stimulation, improves or slows progression of cognitive decline in patients with moderate to advanced Parkinson's disease having mild cognitive impairment, and to evaluate the effect of NBM stimulation on gait and balance impairment.
Study Design: Prospective single center Phase 1 study with double-blind randomized delayed activation of basal nucleus of Meynert neurostimulation (staggered onset design).
Planned Number of Subjects: 10 patients.
Planned Number of Sites / Countries: Single center in Brazil.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 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: 50 - 75 years.
- •Diagnosis of idiopathic PD according to Movement Disorders Society (MDS) criteria (Albanese et al., 2017).
- •Mild cognitive impairment (MCI) related to Parkinson's disease according to MDS criteria. (Livtan et al. 2012).
- •Duration of bilateral idiopathic PD: ≥ 5 years of motor symptoms.
- •Modified Hoehn and Yahr stage ≥ 2 on off medication state.
- •UPDRS subset III (motor) ≥ 30 points on off medication state.
- •Levodopa must improve PD symptoms by ≥ 30% in a levodopa challenge test, as measured by UPDRS subset III score.
- •Presence of motor complications related to Parkinson's disease.
- •Be willing and able to comply with all visits and study related procedures
- •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.
排除标准
- •Alcohol or drug abuse.
- •Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
- •Contraindications for deep brain stimulation (DBS) surgery.
- •Heart failure, heart disease or any condition that contraindicates surgical procedures.
- •Pacemaker or other active implanted stimulators.
- •Clearly established Parkinson's disease dementia according to Movement Disorders Criteria.
- •Participation in another drug, device, or biologics trial concurrently.
结局指标
主要结局
Safety of combined bilateral Globus Pallidus internus (GPi) and Nucleus Basalis of Meynert (NBM) stimulation in patients with moderate to advanced Parkinson's disease with mild cognitive impairment as determined by reported adverse events.
时间窗: 36 weeks
Safety of combined bilateral GPi and NBM stimulation in patients with moderate to advanced Parkinson's disease having mild cognitive impairment as determined by reported adverse events.
次要结局
- Change in Verbal Fluency Battery.(36 weeks)
- Change in Parkinson's Disease - Cognitive Rating Scale (PD-CRS).(36 weeks)
- Change in Trail Making Task.(36 weeks)
- Change in Symbol Digit Modalities Test.(36 weeks)
- Change in Mattis Dementia Rating Scale.(36 weeks)
- Change in Stroop Test.(36 weeks)
- Change in Parkinson's Disease Questionnaire for quality of life (PDQ-39).(36 weeks)
- Change in Unified Parkinson's Disease Rating Scale section I (UPDRS I).(36 weeks)
- Change in Unified Parkinson's Disease Rating Scale section IV (UPDRS IV).(36 weeks)
- Change in objective assessment of gait measured by a sensor (MobilityLab) that assess number of steps per minute.(36 weeks)
- Change in objective assessment of gait measured by a sensor (MobilityLab) that assess distance between heels.(36 weeks)
- Change in Questionnaire of the EuroQol-group (EQ-5D-5L).(36 weeks)
- Change in Unified Parkinson's Disease Rating Scale section II (UPDRS II).(36 weeks)
- Change in Unified Parkinson's Disease Rating Scale section III (UPDRS III).(36 weeks)
- Change in objective assessment of gait measured by a sensor (MobilityLab) that assess step speed.(36 weeks)
- Change in objective assessment of gait measured by a sensor (MobilityLab) that assess balance.(36 weeks)
- Change in New Freezing of Gait Questionnaire (N-FOG).(36 weeks)
- Change in objective assessment of gait measured by Time Up and Go dual task - Test 3 meters (TUG dual task - test 3M).(36 weeks)
- Change in objective assessment of gait measured by freezing of gait score (FOG score).(36 weeks)
- Change in objective assessment of gait measured by Time Up and Go - Test 3 meters (TUG test 3M).(36 weeks)
- Change in Activities-Specific Balance Confidence Scale (ABC scale).(36 weeks)
- Change in Beck Depression Inventory (BDI).(36 weeks)
- Change in Beck Anxiety Inventory (BAI).(36 weeks)
- Change in Starkstein Apathy Scale.(36 weeks)
- Change in Falls Efficacy Scale International (FES-I).(36 weeks)
- Change in Neuropsychiatric Inventory (NPI).(36 weeks)
- Change in Ardouin Scale of Behavior in Parkinson's Disease.(36 weeks)