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Deep Brain Stimulation (DBS) for Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658125
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : September 27, 2019
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto

Brief Summary:

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: Bilateral fornix DBS implantation, Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease
Actual Study Start Date : March 1, 2007
Actual Primary Completion Date : June 30, 2010
Actual Study Completion Date : June 30, 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental Procedure: Bilateral fornix DBS implantation,
Fornix DBS for Alzheimer Disease
Other Name: DBS

Primary Outcome Measures :
  1. memory performance on neuropsychological tests [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00658125

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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
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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
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Responsible Party: Andres M. Lozano, Professor of Surgery, University Health Network, Toronto Identifier: NCT00658125    
Other Study ID Numbers: 06-0095-B
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders