Efficacy of Computerized Cognitive Training in the Elderly With Mild Cognitive Impairment
NCT ID: NCT03577717
Last Updated: 2020-02-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
7 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-07-13
Study Completion Date
2019-03-11
Brief Summary
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Mild cognitive impairment (MCI) is the prodrome of the cognitive function declining before Alzheimer's disease or other dementia showed up, the impairments of language, visuospatial relationship, attention, and memory included and instrumental activities of daily living (IADL) influenced. MCI is considered as a transitional stage between normal aging and mild dementia, and the patients with MCI has differently fluctuated cognitive functions in a period of time, such as from normal cognition to MCI or developing to dementia. The annual conversion rate (ACR) of older adults with normal cognition developed to MCI is 30%, and 5% in clinical setting, and community, respectively. Not all of patients with MCI develop to Alzheimer's disease, the reversion of patients with MCI to normal cognition exists. However, MCI is a significant risk factor. The ACR of older adults with normal cognition or MCI developed to dementia is 1-2%, and 5-15%, respectively; moreover, about half of patients with MCI developed to dementia in 5 years.
Cognitive training (CT) improves cognitive functions with repetitive practicing standardized cognitive tasks of specific cognitive functions, such as memory, attention, or problem solving. CT has widely defined including strategy training, in which contained cognitive exercise, strategy indicating and practicing to reducing cognitive impairments and improving performances. CT is more effective for MCI. Recently, computer-based CT (CCT) with many advantages gradually replaced the traditional paper-pencil form. Brief systematic review showed that the computer-based intervention had positive effects on behavioral symptoms, such as depression and anxiety, in patients with MCI and/or dementia. Previous studies demonstrated that computer-based intervention exhibited moderate treatment effects on overall cognitive functions in patients with MCI, and also had positive effects on learning, short-term memory, and behavioral symptoms.
Older people with cognitive impairments is expected to increase by global aging. It is important for improving or maintaining cognitive functions of older adults with MCI. The efficacy of the CCT on cognitive functions, neuropsychiatric symptoms, daily functions, and brain activated imaging of the magnetoencephalography (MEG) of in older adults with MCI is worth to explore for busy clinical practice.
Cognitive training (CT) improves cognitive functions with repetitive practicing standardized cognitive tasks of specific cognitive functions, such as memory, attention, or problem solving. CT has widely defined including strategy training, in which contained cognitive exercise, strategy indicating and practicing to reducing cognitive impairments and improving performances. CT is more effective for MCI. Recently, computer-based CT (CCT) with many advantages gradually replaced the traditional paper-pencil form. Brief systematic review showed that the computer-based intervention had positive effects on behavioral symptoms, such as depression and anxiety, in patients with MCI and/or dementia. Previous studies demonstrated that computer-based intervention exhibited moderate treatment effects on overall cognitive functions in patients with MCI, and also had positive effects on learning, short-term memory, and behavioral symptoms.
Older people with cognitive impairments is expected to increase by global aging. It is important for improving or maintaining cognitive functions of older adults with MCI. The efficacy of the CCT on cognitive functions, neuropsychiatric symptoms, daily functions, and brain activated imaging of the magnetoencephalography (MEG) of in older adults with MCI is worth to explore for busy clinical practice.
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Detailed Description
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The study design was a prospective and single-blinded randomized controlled trial. 36 participants with MCI were recruited and demographic data (age, gender, education level /years of education, marriage status etc.) were also collected. The MCI participants underwent the comprehensive review at baseline including neuropsychological assessment and Magnetic Resonance Imaging or Computerized Tomogram. Randomization treatment assignment will be generated by the random number table and assign the patient's intervention group accordingly. Sealed opaque envelopes containing the CCT group, or the dosage-matched control group sheets will be prepared and given to the therapists.
Based on the t-test effect size of index d 1.00 indicates, an estimated 17 participants in each group will be required for a power of 0.80 with a two-sided type I error of 0.05. Considering the 5% (q) drop rate, we will need to recruit 18 participants (N/1-q) for each group. The participants were randomly allocated to either the CCT group (18 participants) or the dosage-matched control group (18 participants) with individualized intervention for 30 minutes a day, 3 times a week for 4 consecutive weeks. Clinical outcome measures, and the imaging of the MEG were administered at pre- treatment, post-treatment and 1-month follow-up for further analysis.
Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 19.0. In statistical testing, two-sided p value ≤ 0.05 was considered statistically significant. The distributional properties of continuous variables were expressed by mean ± standard deviation (SD), categorical variables were presented by frequency and percentage. The differences in the distributions of continuous variables, categorical variables between the treatment and control groups were examined using two-sample t-test, Wilcoxon rank-sum test (or Mann-Whitney U test), and chi-square test. In addition, the minimum norm estimates (MNE), source-based time-frequency analysis, cross-frequency coupling, and functional connectivity were used to explore the differences of the activation of brain functions in participants between different treatment groups. The t-test was used to explore the differences of reaction time, rate of correction, and physical signals in stimulus reaction test of the MEG between in participants between different treatment groups. The correlation statistics was used to explore relationships between the scores of outcome measurements and the physical signals.
Based on the t-test effect size of index d 1.00 indicates, an estimated 17 participants in each group will be required for a power of 0.80 with a two-sided type I error of 0.05. Considering the 5% (q) drop rate, we will need to recruit 18 participants (N/1-q) for each group. The participants were randomly allocated to either the CCT group (18 participants) or the dosage-matched control group (18 participants) with individualized intervention for 30 minutes a day, 3 times a week for 4 consecutive weeks. Clinical outcome measures, and the imaging of the MEG were administered at pre- treatment, post-treatment and 1-month follow-up for further analysis.
Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 19.0. In statistical testing, two-sided p value ≤ 0.05 was considered statistically significant. The distributional properties of continuous variables were expressed by mean ± standard deviation (SD), categorical variables were presented by frequency and percentage. The differences in the distributions of continuous variables, categorical variables between the treatment and control groups were examined using two-sample t-test, Wilcoxon rank-sum test (or Mann-Whitney U test), and chi-square test. In addition, the minimum norm estimates (MNE), source-based time-frequency analysis, cross-frequency coupling, and functional connectivity were used to explore the differences of the activation of brain functions in participants between different treatment groups. The t-test was used to explore the differences of reaction time, rate of correction, and physical signals in stimulus reaction test of the MEG between in participants between different treatment groups. The correlation statistics was used to explore relationships between the scores of outcome measurements and the physical signals.
Conditions
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Mild Cognitive Impairment
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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computerized cognitive training
participants will be trained by the "Cookies for the brainy day", including memory, attention, calculation, executive functions, and language training.
Group Type
EXPERIMENTAL
computerized cognitive training
Intervention Type
OTHER
participants will be trained 30 minutes/day, 3 days/week for 4 consecutive weeks.
occupational therapy
participants will receive craft activities of occupational therapy, such as weaving, origami etc.
Group Type
ACTIVE_COMPARATOR
occupational therapy
Intervention Type
OTHER
participants will receive craft activities of occupational therapy for 30 minutes/day, 3 days/week for 4 consecutive weeks.
Interventions
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computerized cognitive training
participants will be trained 30 minutes/day, 3 days/week for 4 consecutive weeks.
Intervention Type
OTHER
occupational therapy
participants will receive craft activities of occupational therapy for 30 minutes/day, 3 days/week for 4 consecutive weeks.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* (1) were aged ≥65 years
* (2) amnestic type MCI was made using National Institute on Aging-Alzheimer's Association workgroups diagnostic guidelines for Alzheimer's disease with the clinical dementia rating scale (CDR) global scores of 0.5
* (3) could follow command, understand the content of the assessments, and cooperate with treatment interventions through verbal communication
* (2) amnestic type MCI was made using National Institute on Aging-Alzheimer's Association workgroups diagnostic guidelines for Alzheimer's disease with the clinical dementia rating scale (CDR) global scores of 0.5
* (3) could follow command, understand the content of the assessments, and cooperate with treatment interventions through verbal communication
Exclusion Criteria
* (1) had the score of Geriatric Depression Scale-Short Form (GDS-SF) \> 7, indicating depression status
* (2) had the score of Barthel Index (BI)≠100, indicating dependent basic daily living of activities
* (3) were diagnosed with other MCI subtypes, including frontotemporal dementia or Lewy Body those present typically different MCI syndromes
* (4) had other neuropsychotic diseases
* (5) could not administrate with MEG
* (6) could not participate due to severe health problem
* (2) had the score of Barthel Index (BI)≠100, indicating dependent basic daily living of activities
* (3) were diagnosed with other MCI subtypes, including frontotemporal dementia or Lewy Body those present typically different MCI syndromes
* (4) had other neuropsychotic diseases
* (5) could not administrate with MEG
* (6) could not participate due to severe health problem
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Taipei Hospital, Taiwan
OTHER
Sponsor Role
lead
Responsible Party
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Wan-ying Chang
occupational therapist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Wan-ying Chang, MS
Role: PRINCIPAL_INVESTIGATOR
Division of Occupational Therapy,Taipei Hospital, Ministry of Health and Welfare
Locations
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Taipei Hospital, Ministry of Health and Welfare
New Taipei City, , Taiwan
Site Status
Countries
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Taiwan
References
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Other Identifiers
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201804
Identifier Type: -
Identifier Source: org_study_id
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NA
The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury
NCT03237676
COMPLETED
NA
Dual-Task Training for People With Mild Cognitive Impairment and Mild Dementia
NCT06348810
NOT_YET_RECRUITING
NA
Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
NCT04615169
COMPLETED
NA
Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment
NCT02785315
COMPLETED
NA
Efficacy of Computer-Based Cognitive Game Training for Healthy Elderly
NCT03940079
COMPLETED
NA
CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI)
NCT03133052
UNKNOWN
NA
Does Computerized Cognitive Training Improve Executive Functioning in the Older Adult?
NCT03170492
UNKNOWN
NA
Guided Training for People With Cognitive Impairment
NCT03225768
COMPLETED
NA
Efficacy of a Multicomponent Cognitive Intervention in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments
NCT04023032
COMPLETED
NA
Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment
NCT03405857
COMPLETED
NA
Cognitive Ability Training for Seniors With Mild Cognitive Impairment
NCT02940457
WITHDRAWN
NA
Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment
NCT03119051
UNKNOWN
NA
Computer-Based Training for Cognitive Enhancement: In Home Study
NCT00337974
COMPLETED
NA
Effects of 24-week Computerized Cognitive Training in Patients With MCI and AD
NCT06094452
COMPLETED
NA
Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
NCT03545152
COMPLETED
NA
Computer-based Cognitive Rehabilitation Program for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
NCT03430401
ACTIVE_NOT_RECRUITING
NA
Motor-cognitive Interventions Are Effective in Improving Cognitive Function in Older Adults With Mild Cognitive impairment--a Chinese Sample
NCT05764421
COMPLETED
NA
Protocol of Virtual Interactive Memory-Training Program
NCT02462135
COMPLETED
NA
The Benefits of the Use of the Feuerstein Cognitive Training Method on Cognitive Function in Community-dwelling Older Patients With Mild Cognitive Impairment: a Pilot Study
NCT02388451
COMPLETED
NA
Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment
NCT02512627
COMPLETED
NA
Yizhi Baduanjin for Patients With Cognitive Impairment
NCT06453941
TERMINATED
NA
Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays
NCT06277440
NOT_YET_RECRUITING
NA