Deep Brain Stimulation (DBS) of the Nucleus Basalis of Meynert (nbM) to Treat Parkinson's Patients With Mild Cognitive Impairment, Amnestic Subtype
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Evaluate safety of DBS-nbM
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation of the nucleus basalis of Meynert (also called the "nbM") at improving memory in Parkinson's disease patients with mild cognitive impairments and memory difficulties. Patients with Parkinson's disease (PD) that are eligible for Deep Brain Stimulation (DBS) therapy for improvement of their motor symptoms and with evidence of mild cognitive impairments and memory difficulties will be enrolled.
详细描述
This is a prospective, double-blind (patient and neuropsychologist), randomized, cross-over study to evaluate the safety of deep brain stimulation of the nucleus basalis of Meynert (nbM) in Parkinson's disease (PD) patients with mild cognitive impairment (PD-MCI) who are undergoing globus pallidus internus (GPi) stimulation for their motor symptoms. Six patients with PD who are eligible for GPi DBS for improvement of their motor symptoms and who have a clinical diagnosis of PD-MCI (amnestic, single or multiple domain) per Movement Disorder Society (MDS) criteria will be enrolled and implanted with bilateral electrodes in in the nbM in addition to the globus pallidus internus (GPi). Conventional stereotactic implantation of the electrodes will be guided by intraoperative computerized tomography (CT) and magnetic resonance tomography (MRT).
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
- Triple (Participant, Investigator, 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
- •Informed consent signed by the subject.
- •Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria
- •Diagnosis of PD-MCI, amnestic subtype per MDS criteria (Level II assessment)
- •DBS candidate for GPi targeting per the consensus committee
- •50 - 75 years of age
- •Primary English speaking
- •Minimum of 10 years of education
- •Motorically and cognitively capable of completing evaluations and consent
- •Medically cleared for surgery and anesthesia
- •Subject must be on stable doses of any medication used to treat PD or cognition for 3 months prior to study entry
- •Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery -
排除标准
- •Dementia per DSM-V criteria
- •Condition precluding MRI
- •History of supraspinal CNS disease other than PD
- •Medical condition or required medication compromising cognition
- •Alcohol use of more than 4 drinks per day
- •Currently uncontrolled moderate-severe depression (BDI>20)
- •History of suicide attempt in the year preceding study screening
- •History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
- •Use of cholinesterase inhibitor
- •Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
- •Subjects with a history of seizure disorder
- •Subjects who have made a suicide attempt within the prior year,
- •Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
- •Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
- •Subjects who are pregnant or nursing.
结局指标
主要结局
Evaluate safety of DBS-nbM
时间窗: Month 36
Evaluate safety through collection of adverse events at weeks 4, 16, 28, 52 and months 24 and 36.
次要结局
- Stability or improvement of cognitive symptoms(Month 36)