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Clinical Trials/NCT00658125
NCT00658125
Completed
N/A

Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease

University Health Network, Toronto1 site in 1 country6 target enrollmentMarch 1, 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University Health Network, Toronto
Enrollment
6
Locations
1
Primary Endpoint
memory performance on neuropsychological tests
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2007
End Date
June 30, 2010
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andres M. Lozano

Professor of Surgery

University Health Network, Toronto

Eligibility 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

Outcomes

Primary Outcomes

memory performance on neuropsychological tests

Time Frame: one year

Study Sites (1)

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