Mild Cognitive ImpairmentCoCoTANCT02480738
Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment
A study testing Computerized Cognitive Training Apparatus in people with Mild Cognitive Impairment, run by Seoul National University Bundang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 51 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Computerized Cognitive Training Apparatus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages >50 to ≤70
- Years of education ≥ 6 years
- No physical barrier preventing the dominant hand from using the computer mouse
Who cannot join
- 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.
About this study
Official title: Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Computerized Cognitive Training Apparatus
- Keywords
- subjective cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Training ApparatusBehavioural
Also called CoCoTA
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild cognitive impairment | Experimental | Intervention: Computerized Cognitive Training Apparatus Receives: Behavioral: Computerized Cognitive Training Apparatus |
| Subjective cognitive impairment | Experimental | Intervention: Computerized Cognitive Training Apparatus Receives: Behavioral: Computerized Cognitive Training Apparatus |
| Normal controls | Active comparator | Intervention: Computerized Cognitive Training Apparatus Receives: Behavioral: Computerized Cognitive Training Apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement in the follow-up neuropsychological tests
changes in memory and frontal domain subscores between the baseline and follow-up
Measured: 12 weeks
Secondary outcomes (4)
Cortical thickness changes between baseline and follow-up volumetric MRI
surface-based morphometry using freesurfer software
Measured: 12 weeks
White matter integrities changes between baseline and follow-up diffusion tensor imaging
tract-based spatial statistics using fsl software
Measured: 12 weeks
Spectral ratio changes between baseline and follow-up EEG
EEG spectral ratio analysis
Measured: 12 weeks
local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
local activation pattern analysis using SPM
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SangYun Kim, Seoul National University Bundang Hospital
- Investigators
- SangYun Kim, MD,PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480738
- Sponsor's protocol ID
- 10035434
- Acronym
- CoCoTA
- Status last verified
- May 2019
- First submitted
- 22 Jun 2015
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30198220
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02480738
- Acronym / sponsor ID
- CoCoTA / 10035434
- Conditions
- Mild Cognitive Impairment
- Keywords
- subjective cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild cognitive impairment | Experimental | Behavioral: Computerized Cognitive Training ApparatusIntervention: Computerized Cognitive Training Apparatus |
| Subjective cognitive impairment | Experimental | Behavioral: Computerized Cognitive Training ApparatusIntervention: Computerized Cognitive Training Apparatus |
| Normal controls | Active comparator | Behavioral: Computerized Cognitive Training ApparatusIntervention: Computerized Cognitive Training Apparatus |
Who may qualify
- Ages
- 51 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages >50 to ≤70
- Years of education ≥ 6 years
- No physical barrier preventing the dominant hand from using the computer mouse
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive Training ApparatusAlso: CoCoTACoCoTA 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. | Behavioural | Mild cognitive impairment, Normal controls, Subjective cognitive impairment |
Primary outcome
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
4 secondary outcomes
Cortical thickness changes between baseline and follow-up volumetric MRI
Time frame: 12 weeks
White matter integrities changes between baseline and follow-up diffusion tensor imaging
Time frame: 12 weeks
Spectral ratio changes between baseline and follow-up EEG
Time frame: 12 weeks
local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Results publication: PubMed 30198220Na 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SangYun Kim, MD,PhD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training Apparatus in people with Mild Cognitive Impairment, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement in the follow-up neuropsychological tests (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.