Deep Brain Stimulation for the Treatment of Alzheimer's Disease
NCT ID: NCT01559220
Last Updated: 2017-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2012-03-31
2016-01-31
Brief Summary
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Detailed Description
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* Expected direct benefit on the modulation of neuronal networks.
* Expected indirect benefit via potential enhancements of memory, executive functions, cognition behavioral control, and functional abilities.
Up to 10 subjects will be implanted with bilateral DBS systems, participants are expected to be on study for about 23 months.
* Develop a multidisciplinary clinical research protocol to evaluate the efficacy of ventral striatum, nucleus accumbens, and internal capsule for the amelioration of disability caused by Alzheimer's Disease.
* Enroll up to 10 patients into an open label study to evaluate the safety and efficacy of DBS for Alzheimer's Disease patients with mild to moderate disability.
* Determine an initial DBS titration and stimulation settings protocol for use in subsequent controlled trials.
* Evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging, cognitive, behavioral, and functional assessments.
* Determine what domains of cognitive, behavioral and functioning impairment show the greatest response to DBS.
* Examine the potential benefit of stimulation combined with behavioral and rehabilitation interventions in comparison to stimulation alone.
* Evaluate the influence of DBS on physiological and functional changes in cortical and subcortical networks.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Open Label
DBS Implant and stimulation
Deep Brain Stimulation
Implanted device
Interventions
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Deep Brain Stimulation
Implanted device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Evidence of substance abuse (alcohol or other drug) abuse or dependence during the previous 12 months (DSM-IV Criteria).
45 Years
85 Years
ALL
No
Sponsors
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Ali Rezai, MD
OTHER
Responsible Party
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Ali Rezai, MD
MD
Principal Investigators
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Ali Rezai, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States
Countries
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Other Identifiers
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2011H0362
Identifier Type: -
Identifier Source: org_study_id
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