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Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment (CoCoTA)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized Cognitive Training Apparatus
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring subjective cognitive impairment

Eligibility Criteria

51 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages >50 to ≤70
  • Years of education ≥ 6 years
  • No physical barrier preventing the dominant hand from using the computer mouse

Exclusion Criteria:

  • Subjects who had any structural lesions or psychiatric disorders that explained the memory deficits
  • Subjects had to be able to undergo pre- and post-training evaluations such as electroencephalography (EEG), FDG-PET, and magnetic resonance imaging (MRI)
  • Subjects who had scalp lesions, severe back pain, or claustrophobia that precluded pre- and post-training evaluations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Mild cognitive impairment

    Subjective cognitive impairment

    Normal controls

    Arm Description

    Intervention: Computerized Cognitive Training Apparatus

    Intervention: Computerized Cognitive Training Apparatus

    Intervention: Computerized Cognitive Training Apparatus

    Outcomes

    Primary Outcome Measures

    Clinical improvement in the follow-up neuropsychological tests
    changes in memory and frontal domain subscores between the baseline and follow-up

    Secondary Outcome Measures

    Cortical thickness changes between baseline and follow-up volumetric MRI
    surface-based morphometry using freesurfer software
    White matter integrities changes between baseline and follow-up diffusion tensor imaging
    tract-based spatial statistics using fsl software
    Spectral ratio changes between baseline and follow-up EEG
    EEG spectral ratio analysis
    local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
    local activation pattern analysis using SPM

    Full Information

    First Posted
    June 22, 2015
    Last Updated
    May 16, 2019
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02480738
    Brief Title
    Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment
    Acronym
    CoCoTA
    Official Title
    Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (Actual)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is to investigate the effectiveness of computerized cognitive training, and corresponding neural substrates through multimodal neuroimaging assessment, in the elderly with normal cognition, subjective cognitive impairment, and mild cognitive impairment.
    Detailed Description
    Computerized cognitive training has the advantage of easy accessibility for community-dwelling elderly. It can be much cheaper than traditional neuropsychological training methods, which require trained neuropsychologists. Furthermore, it may be more fun and easier to be optimized to an individual patients' cognitive status than other traditional methods. Clinical efficacy of these kinds of cognitive training applications has been validated through several studies. A recent systematic review reported that the domains of working memory, executive function, and processing speed benefited the most by classic computerized cognitive training tasks, and that these benefits were comparable with traditional cognitive training methods. Apart from neuropsychological data, neuroimaging studies focusing on the effectiveness of computerized cognitive training are scant. There have been no previous studies investigating the possible neural substrates of computerized cognitive training using multimodal neuroimaging modalities simultaneously. Thus, we aimed to investigate the effectiveness of computerized cognitive training and corresponding neural substrates in subjects with mild cognitive impairment, subjective memory impairment, and normal controls through a multimodal approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment
    Keywords
    subjective cognitive impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mild cognitive impairment
    Arm Type
    Experimental
    Arm Description
    Intervention: Computerized Cognitive Training Apparatus
    Arm Title
    Subjective cognitive impairment
    Arm Type
    Experimental
    Arm Description
    Intervention: Computerized Cognitive Training Apparatus
    Arm Title
    Normal controls
    Arm Type
    Active Comparator
    Arm Description
    Intervention: Computerized Cognitive Training Apparatus
    Intervention Type
    Behavioral
    Intervention Name(s)
    Computerized Cognitive Training Apparatus
    Other Intervention Name(s)
    CoCoTA
    Intervention Description
    CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia. Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.
    Primary Outcome Measure Information:
    Title
    Clinical improvement in the follow-up neuropsychological tests
    Description
    changes in memory and frontal domain subscores between the baseline and follow-up
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Cortical thickness changes between baseline and follow-up volumetric MRI
    Description
    surface-based morphometry using freesurfer software
    Time Frame
    12 weeks
    Title
    White matter integrities changes between baseline and follow-up diffusion tensor imaging
    Description
    tract-based spatial statistics using fsl software
    Time Frame
    12 weeks
    Title
    Spectral ratio changes between baseline and follow-up EEG
    Description
    EEG spectral ratio analysis
    Time Frame
    12 weeks
    Title
    local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
    Description
    local activation pattern analysis using SPM
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    51 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ages >50 to ≤70 Years of education ≥ 6 years No physical barrier preventing the dominant hand from using the computer mouse Exclusion Criteria: Subjects who had any structural lesions or psychiatric disorders that explained the memory deficits Subjects had to be able to undergo pre- and post-training evaluations such as electroencephalography (EEG), FDG-PET, and magnetic resonance imaging (MRI) Subjects who had scalp lesions, severe back pain, or claustrophobia that precluded pre- and post-training evaluations.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SangYun Kim, MD,PhD
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30198220
    Citation
    Na HR, Lim JS, Kim WJ, Jang JW, Baek MJ, Kim J, Park YH, Park SY, Kim S. Multimodal Assessment of Neural Substrates in Computerized Cognitive Training: A Preliminary Study. J Clin Neurol. 2018 Oct;14(4):454-463. doi: 10.3988/jcn.2018.14.4.454. Epub 2018 Jun 26.
    Results Reference
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    Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment

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