Deep Brain Stimulation (DBS) for Alzheimer's Disease

NCT ID: NCT00658125

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-01
• Study Completion Date: 2010-06-30

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

Bilateral fornix DBS implantation,

Intervention Type: PROCEDURE

Fornix DBS for Alzheimer Disease

Interventions

Bilateral fornix DBS implantation,

Fornix DBS for Alzheimer Disease

Intervention Type: PROCEDURE

Other Intervention Names

DBS

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Andres M. Lozano

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian W Laxton, MD

Role: STUDY_DIRECTOR

Toronto Western Research Institute

Andres M Lozano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Research Institute

David Tang-Wai, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Research Institute

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 18232017 (View on PubMed)

Other Identifiers

06-0095-B

Identifier Type: -

Identifier Source: org_study_id