Deep Brain Stimulation (DBS) for Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Procedure: Bilateral fornix DBS implantation,

• Registration Number: NCT00658125
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Primary Completion: 2010-06-30
• Study Completion: 2010-06-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

• Pre-existing structural brain abnormalities,
• Other neurologic or psychiatric diagnoses, or
• Medical comorbidities that would preclude them from undergoing surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Bilateral fornix DBS implantation,	-

Primary Outcome Measures

Name	Time	Method
memory performance on neuropsychological tests	one year

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada