Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- memory performance on neuropsychological tests
研究概览
简要总结
Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human.
Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain.
Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 40 to 80 years old, who
- •Satisfy the diagnostic criteria for probable AD,
- •Have received the diagnosis of AD within the past 2 years,
- •Have a CDR of 0.5 or 1.0, and
- •Score between 20 and 28 on the Mini Mental State Examination
排除标准
- •Pre-existing structural brain abnormalities,
- •Other neurologic or psychiatric diagnoses, or
- •Medical comorbidities that would preclude them from undergoing surgery
研究组 & 干预措施
Experimental
干预措施: Bilateral fornix DBS implantation, (Procedure)
结局指标
主要结局
memory performance on neuropsychological tests
时间窗: one year
次要结局
未报告次要终点
研究者
Andres M. Lozano
Professor of Surgery
University Health Network, Toronto
