Deep Brain Stimulation (DBS) for Alzheimer's Disease
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Alzheimer Disease |
Procedure: Deep Brain Stimulation (Fornix DBS) |
Phase 1 |
| Study Type: | Interventional |
| 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 6 |
| 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)
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pre-existing structural brain abnormalities,
- Other neurologic or psychiatric diagnoses, or
- Medical comorbidities that would preclude them from undergoing surgery
Contacts and Locations| Canada, Ontario | |
| 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 |
More Information
Publications:
| Responsible Party: | Andres Lozano, Professor, University of Toronto |
| ClinicalTrials.gov Identifier: | NCT00658125 History of Changes |
| Other Study ID Numbers: | 06-0095-B |
| Study First Received: | April 9, 2008 |
| Last Updated: | April 7, 2010 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013