Deep Brain Stimulation (DBS) for Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00658125|
Recruitment Status : Unknown
Verified January 2010 by University Health Network, Toronto.
Recruitment status was: Active, not recruiting
First Posted : April 14, 2008
Last Update Posted : April 8, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Procedure: Deep Brain Stimulation (Fornix DBS)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2010|
Procedure: Deep Brain Stimulation (Fornix DBS)
- memory performance on neuropsychological tests [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|