Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (NbM) in Patients With Parkinson's Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 13
- 主要终点
- Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)
研究概览
简要总结
The existing DBS setting in patients with DBS of the globus pallidus interna (GPi), which aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed to stimulate the NbM at a low frequency using the distal electrodes positioned in the vicinity of the NBM.
This study aims to investigate the neuropsychological effect of low frequency stimulation of the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).
详细描述
The existing DBS setting in patients with GPi DBS, which aims to treat motor symptoms by a high-frequency stimulation, will be temporarily reprogramed to stimulate the NBM at a low frequency using the distal electrodes positioned in the vicinity of the NBM.This study consists of a three-day screening study of the NbM stimulation followed by a two-week, randomized, single-blind, crossover trial. Between the screening study and the crossover trial, one week of washout period will be applied to eliminate potential carryover effect from the previous stimulation.
This study aims to investigate the neuropsychological effect of low frequency stimulation of the nucleus basalis of Meynert (NBM) in advanced Parkinson's disease (PD) patients, who were previously treated with deep brain stimulation (DBS) of the globus pallidus interna (GPi).
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with GPi stimulation, with the NBM within the vicinity of the electric field of at least one DBS electrode.
- •Patients should be able to give informed consent
- •Patients should be on a stable medication regimen for at least 4 weeks
排除标准
- •any unstable internal disease
- •Subject with significant worsening of motor function during the pilot screening study, which is indicated by an increase of the UPDRS part III score more than 30%, will not continue to the crossover trial
结局指标
主要结局
Changes in global cognitive function measured by the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG)
时间窗: 2 weeks of the crossover trial phase
次要结局
- Changes of Unified Parkinson's Disease Rating Scale (UPDRS) part 3(3 days of the screening phase)
- Changes of the power of background EEG frequencies(2 weeks of the crossover trial phase)
- Score changes of the Hospital Anxiety and Depression Scale(2 weeks of the crossover trial phase)
- Score changes of the Apathy Evaluation Scale(2 weeks of the crossover trial phase)
- Score changes of the digit span test of Wechsler Adult Intelligence Scale III(2 weeks of the crossover trial phase)
- Score changes of stroop test(2 weeks of the crossover trial phase)
- Score changes of the Trail Making test(2 weeks of the crossover trial phase)
- Score changes of the symbol digit modality test (SDMT)(2 weeks of the crossover trial phase)
研究者
Teus van Laar
Prof. Dr.
University Medical Center Groningen