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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
  Purpose
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.

Condition Intervention
Alzheimer's Disease Device: Deep Brain Stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Device Feasibility
Official Title: Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Ali Rezai, MD, The Ohio State University:

Primary Outcome Measures:
  • Clinical Dementia Rating Scale [ Time Frame: 24 months ]

Enrollment: 3
Study Start Date: March 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label
DBS Implant and stimulation
Device: Deep Brain Stimulation
Implanted device
Other Name: Deep Brain Stimulation Device

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.
  Eligibility

Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559220

Locations
United States, Ohio
Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ali Rezai, MD
Investigators
Principal Investigator: Ali Rezai, MD Ohio State University
  More Information

Responsible Party: Ali Rezai, MD, MD, The Ohio State University
ClinicalTrials.gov Identifier: NCT01559220     History of Changes
Other Study ID Numbers: 2011H0362
Study First Received: March 19, 2012
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: 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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 27, 2017