- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02480738
Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment (CoCoTA)
Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mild cognitive impairment
Intervention: 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 Names:
|
|
Experimental: Subjective cognitive impairment
Intervention: 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 Names:
|
|
Active Comparator: Normal controls
Intervention: 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical thickness changes between baseline and follow-up volumetric MRI
Time Frame: 12 weeks
|
surface-based morphometry using freesurfer software
|
12 weeks
|
|
White matter integrities changes between baseline and follow-up diffusion tensor imaging
Time Frame: 12 weeks
|
tract-based spatial statistics using fsl software
|
12 weeks
|
|
Spectral ratio changes between baseline and follow-up EEG
Time Frame: 12 weeks
|
EEG spectral ratio analysis
|
12 weeks
|
|
local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
Time Frame: 12 weeks
|
local activation pattern analysis using SPM
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: SangYun Kim, MD,PhD, Seoul National University Bundang Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10035434
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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