Full Text View
Tabular View
No Study Results Posted
Related Studies
Deep Brain Stimulation (DBS) for Alzheimer's Disease
This study is currently recruiting participants.
Verified by University Health Network, Toronto, April 2008
First Received: April 9, 2008   Last Updated: April 11, 2008   History of Changes
Sponsored by: University Health Network, Toronto
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00658125
  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 I

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Memory
U.S. FDA Resources
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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Deep Brain Stimulation (Fornix DBS)
    Fornix DBS for Alzheimer Disease
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658125

Contacts
Contact: Adrian W Laxton, MD 416-993-5683 adrian.laxton@utoronto.ca

Locations
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            
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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: 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

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009