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Deep Brain Stimulation for the Treatment of Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01559220
First received: March 19, 2012
Last updated: March 28, 2017
Last verified: March 2017

March 19, 2012
March 28, 2017
March 2012
January 2016   (Final data collection date for primary outcome measure)
Clinical Dementia Rating Scale [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT01559220 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation for the Treatment of Alzheimer's Disease
Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease
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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Device Feasibility
Alzheimer's Disease
Device: Deep Brain Stimulation
Implanted device
Other Name: Deep Brain Stimulation Device
Experimental: Open Label
DBS Implant and stimulation
Intervention: Device: Deep Brain Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
January 2016
January 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
45 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01559220
2011H0362
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
No
Not Provided
Ali Rezai, MD, The Ohio State University
Ali Rezai, MD
Not Provided
Principal Investigator: Ali Rezai, MD Ohio State University
Ohio State University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP