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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00658125 |
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 | Intervention | Phase |
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Alzheimer Disease |
Procedure: Deep Brain Stimulation (Fornix DBS) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease |
Estimated Enrollment: | 6 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Adrian W Laxton, MD | 416-993-5683 | adrian.laxton@utoronto.ca |
Canada, Ontario | |
Toronto Western Hospital | Recruiting |
Toronto, Ontario, Canada, M5T 2S8 | |
Contact: Adrian W Laxton, MD 416-993-5683 adrian.laxton@utoronto.ca | |
Principal Investigator: Andres M Lozano, MD, PhD | |
Sub-Investigator: Adrian W Laxton, MD | |
Principal Investigator: David Tang-Wai, MD |
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 |
Responsible Party: | University of Toronto ( Andres Lozano, Professor ) |
Study ID Numbers: | 06-0095-B |
Study First Received: | April 9, 2008 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00658125 History of Changes |
Health Authority: | Canada: Health Canada |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |