NCT01559220CompletedNot Applicable
Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease
Ali Rezai, MD1 site in 1 country3 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Clinical Dementia Rating Scale
Study Overview
Brief Summary
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.
Detailed Description
Open label pilot study
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Exclusion Criteria
- •Has significant neurological disease, other than Alzheimer's disease, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
- •Evidence of substance abuse (alcohol or other drug) abuse or dependence during the previous 12 months (DSM-IV Criteria).
Arms & Interventions
Open Label
Experimental
DBS Implant and stimulation
Intervention: Deep Brain Stimulation (Device)
Outcomes
Primary Outcomes
Clinical Dementia Rating Scale
Time Frame: 24 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Ali Rezai, MD
MD
Ohio State University
Study Sites (1)
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