Back to resultsDeep Brain Stimulation for the Treatment of Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional device feasibility trial for Alzheimer's Disease
Eligibility Criteria
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).
Sites / Locations
- Wexner Medical Center at the Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label
Arm Description
DBS Implant and stimulation
Outcomes
Primary Outcome Measures
Clinical Dementia Rating Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01559220
Brief Title
Deep Brain Stimulation for the Treatment of Alzheimer's Disease
Official Title
Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali Rezai, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Experimental
Arm Description
DBS Implant and stimulation
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Other Intervention Name(s)
Deep Brain Stimulation Device
Intervention Description
Implanted device
Primary Outcome Measure Information:
Title
Clinical Dementia Rating Scale
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Rezai, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wexner Medical Center at the Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Deep Brain Stimulation for the Treatment of Alzheimer's Disease
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