Effects of Nucleus Basalis of Meynert Area Electrical Stimulation on Cognitive Behavioral Disorders in Dementia With Lewy Bodies : A Pilot Phase 1 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- free recalls of the FCSRT
研究概览
简要总结
Deep brain stimulation has been developed as a substitute for the classical lesioning methods previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of Meynert (NBM) may improve cognitive performances, especially the memory tasks.
The present study aims to assess the effect of bilateral electrical stimulation of the NBM on the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate, Dementia with Lewy Bodies.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable Lewy-body dementia according to the internationally accepted consensus criteria (McKeith, 2005)
- •Outpatients, male or female, aged between 18 to 75 years
- •Moderate dementia defined by a mini-mental state examination (MMSE) score between 16 and 26
- •Stable dose of cholinesterase inhibitors (maximal dose tolerated) for a minimum of 1 months
- •Patients receiving antiparkinsonian treatment unmodified for 3 months, if treated
- •French as native language
- •Written informed consent of the patient
- •Written informed consent of the caregiver
排除标准
- •Other causes of dementia (Alzheimer dementia, vascular dementia, dementia associated with Parkinson's disease)
- •Other causes of extrapyramidal symptoms (Parkinson's disease)
- •Patients with a history of severe psychiatric disorders, such as psychosis. Earlier episodes of depression and/or anxiety without hospitalization are not exclusion criteria
- •Contraindications for MR imaging (claustrophobia, metallic foreign bodies, pacemakers, etc)
- •MRI evidence of cerebral microbleeds
- •Surgical contraindications: especially, hemostatic disorders, severe cortical atrophy
- •Patients receiving treatments that may interfere with the cholinergic system: anticholinergics, cholinomimetics.
- •Patients receiving neuroleptics
- •Patients with a history of alcohol or drug abuse
- •Pre-existing structural brain abnormalities (such as tumor, infarction, or intracranial hematoma)
- •Previous neurosurgical intervention
- •Patients with a progressively fatal disease, or life expectancy £ one year
- •Severe visual deficit of ophthalmic origin (such as glaucoma, age related macular degeneration, cataract)
- •Fertile women not using adequate contraceptive methods
- •Women who are pregnant or breast feeding
结局指标
主要结局
free recalls of the FCSRT
时间窗: between the assessments (Month 7) and (Month 10)
The primary endpoint of the study is the difference in the sum of the three free recalls of the FCSRT between the assessments (M7) and (M10), i.e. the comparison of the performances with and without NBM electrical stimulation.
次要结局
- performances on different tests(different tests recorded at Month 7 and Month 10)