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

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ClinicalTrials.gov Identifier: NCT02480738
Recruitment Status : Unknown
Verified June 2015 by SangYun Kim, Seoul National University Bundang Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
SangYun Kim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Computerized Cognitive Training Apparatus Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment
Study Start Date : June 2012
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Mild cognitive impairment
Intervention: Computerized Cognitive Training Apparatus
Behavioral: Computerized Cognitive Training Apparatus

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.

Other Name: CoCoTA

Experimental: Subjective cognitive impairment
Intervention: Computerized Cognitive Training Apparatus
Behavioral: Computerized Cognitive Training Apparatus

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.

Other Name: CoCoTA

Active Comparator: Normal controls
Intervention: Computerized Cognitive Training Apparatus
Behavioral: Computerized Cognitive Training Apparatus

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.

Other Name: CoCoTA




Primary Outcome Measures :
  1. Clinical improvement in the follow-up neuropsychological tests [ Time Frame: 12 weeks ]
    changes in memory and frontal domain subscores between the baseline and follow-up


Secondary Outcome Measures :
  1. Cortical thickness changes between baseline and follow-up volumetric MRI [ Time Frame: 12 weeks ]
    surface-based morphometry using freesurfer software

  2. White matter integrities changes between baseline and follow-up diffusion tensor imaging [ Time Frame: 12 weeks ]
    tract-based spatial statistics using fsl software

  3. Spectral ratio changes between baseline and follow-up EEG [ Time Frame: 12 weeks ]
    EEG spectral ratio analysis

  4. local activation pattern changes between baseline and follow-up Fludeoxyglucose PET [ Time Frame: 12 weeks ]
    local activation pattern analysis using SPM



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Ages Eligible for Study:   51 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480738


Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: SangYun Kim, MD,PhD Seoul National University Bundang Hospital

Responsible Party: SangYun Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02480738     History of Changes
Other Study ID Numbers: 10035434
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by SangYun Kim, Seoul National University Bundang Hospital:
subjective cognitive impairment

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders