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

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring subjective cognitive impairment
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.
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
NCT ID
NCT02480738
First Posted
June 22, 2015
Last Updated
May 16, 2019
Sponsor
Seoul National University Bundang Hospital
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
result
Learn more about this trial
Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment
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