Deep Brain Stimulation (DBS) for Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Health Network, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00658125
First received: April 9, 2008
Last updated: April 7, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


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 2010
Estimated Primary Completion Date: June 2010 (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

Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
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: 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 April 20, 2014