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Deep Brain Stimulation (DBS) for Alzheimer's Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00658125
Enrollment
6
Registered
2008-04-14
Start date
2007-03-01
Completion date
2010-06-30
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

PROCEDUREBilateral fornix DBS implantation,

Fornix DBS for Alzheimer Disease

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
memory performance on neuropsychological testsone year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026