Deep Brain Stimulation (DBS) for Alzheimer's Disease
This trial is active, not recruiting.
|Treatment||deep brain stimulation (fornix dbs)|
|Sponsor||University Health Network, Toronto|
|Start date||March 2007|
|End date||June 2010|
|Trial size||6 participants|
|Trial identifier||NCT00658125, 06-0095-B|
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.
|Intervention model||single group assignment|
memory performance on neuropsychological tests
time frame: one year
Male or female participants from 40 years up to 80 years old.
- 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
- Pre-existing structural brain abnormalities,
- Other neurologic or psychiatric diagnoses, or
- Medical comorbidities that would preclude them from undergoing surgery
|Official title||Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease|
|Principal investigator||Andres M Lozano, MD, PhD|
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