Deep Brain Stimulation (DBS) for Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658125
• Other study ID #: 06-0095-B
• Status: Completed
• Phase: N/A
• Start date: March 1, 2007
• Est. completion date: June 30, 2010

Study information

• Verified date: September 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 30, 2010
• Est. primary completion date: June 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Procedure:
• Bilateral fornix DBS implantation,
Fornix DBS for Alzheimer Disease

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Hamani C, McAndrews MP, Cohn M, Oh M, Zumsteg D, Shapiro CM, Wennberg RA, Lozano AM. Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Ann Neurol. 2008 Jan;63(1):119-23. doi: 10.1002/ana.21295. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	memory performance on neuropsychological tests		one year