Deep Brain Stimulation (DBS) for Alzheimer's Disease
Recruitment status was: Active, not recruiting
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.
|Alzheimer Disease||Procedure: Deep Brain Stimulation (Fornix DBS)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease|
- memory performance on neuropsychological tests [ Time Frame: one year ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Procedure: Deep Brain Stimulation (Fornix DBS)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658125
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Study Director:||Adrian W Laxton, MD||Toronto Western Research Institute|
|Principal Investigator:||Andres M Lozano, MD, PhD||Toronto Western Research Institute|
|Principal Investigator:||David Tang-Wai, MD||Toronto Western Research Institute|