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临床试验/NCT00658125
NCT00658125已完成不适用

Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2007年3月1日最近更新:
适应症
干预措施

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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres M. Lozano

Professor of Surgery

University Health Network, Toronto

研究点 (2)

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