Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cognitive rehabilitation program
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, cognitive training program
Eligibility Criteria
Inclusion Criteria:
- Patients who are diagnosed with mild cognitive impairment through clinical interview, neuropsychological tests and brain imaging
- No history of neurologic diseases
Exclusion Criteria:
- Severe cognitive problems(MMSE<10)
- Other psychiatric disorder including bipolar or schizophrenic disorder
- Other problems disturbing cognitive tests
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1
Group 2
Arm Description
Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day
No intervention will be administered
Outcomes
Primary Outcome Measures
Change from baseline performance on Digit Span Test (Neuropsychological test) at 4 weeks and 8 weeks
It measures auditory attention span and includes forward and backward trials. The participant listens to a series of numbers and calls the sequence correctly. The sequence increases in each trial. The final score is the longest number of sequential digits that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
Change from baseline performance on Visual Span Test (Neuropsychological test) at 4 weeks and 8 weeks
It measures spatial attention span and includes forward and backward trials. The participant will see sequence of blocks "lit up" on a computer screen, and then repeat the sequence in order or back in order. The sequence increases in each trial. The final score is the longest number of sequential blocks that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
Change from baseline performance on Visual Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
It measures a participant's visual sustained and selective attention. The participant will see numbers from "0" to "9" presented on a computer screen and they must click the mouse when "3" appeared. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.
Change from baseline performance on Auditory Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
It measures a participant's auditory sustained and selective attention. The participant will hear numbers from "0" to "9", and when they hear "3" they must click the mouse. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.
Change from baseline performance on Trail Making Test (Neuropsychological test) at 4 weeks and 8 weeks
It consists of type A and type B trials. The participant should connect the numbers (1~25) as quickly as possible in type A trial, and connect the numbers (1~13) and alphabets (A~L) alternatively as quickly as possible in type B trial. The main scores produced in this test are completion time and errors. Higher score means worse performance.
Change from baseline performance on Stroop test (Neuropsychological test) at 4 weeks and 8 weeks
It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.
Change from baseline performance on Visual Recognition test (Neuropsychological test) at 4 weeks and 8 weeks
It measures participant's visual memory. The participant will see 15 visual patterns presented on a computer screen and recognize them immediately. The participant will be asked to recognize the 15 patterns after 20 minutes again. The main scores produced in this test are the numbers of recognized patterns in immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) at 4 weeks and 8 weeks
It measures participant's verbal memory. The participant will hear 15 words and recall them immediately and after 20 minutes again. The main scores produced in this test are the numbers of recalled words of the immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
Secondary Outcome Measures
Change from baseline score on Korean Version of Geriatric Depression Test Short Form (Depression scale) at 4 weeks and 8 weeks
It measures depressive symptoms of the participants. The score ranges between 0 and 15. Higher score means severe depression.
Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) at 4 weeks and 8 weeks
It measures brain activity during cognitive tasks to see if cognitive training affects brain function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03405857
Brief Title
Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment
Official Title
Effects of the Cognitive Enhancing Information & Communication Technology (ICT) Contents in Patients With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 25, 2016 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
April 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of cognitive rehabilitation program on the improvement of cognitive functions in patients with mild cognitive impairment(MCI).
Detailed Description
The cognitive rehabilitation program was developed to improve cognitive functions of the elderly or patients with cognitive impairments. The study will enroll 40 patients with mild cognitive impairment(MCI) between 55 and 75 years of age. Forty subjects will be randomly assigned into two groups. Subjects in the intervention group will receive four weeks of cognitive rehabilitation training, three times per week and 30 minutes per day. The control group will not receive any intervention. The investigator will measure their cognitive and brain functions three times at pre-intervention, post-intervention and four weeks after intervention to assess the effectiveness of the cognitive training program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
mild cognitive impairment, cognitive training program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
No intervention will be administered
Intervention Type
Other
Intervention Name(s)
Cognitive rehabilitation program
Other Intervention Name(s)
Computer-aided Cognitive Rehabilitation Training System
Intervention Description
Cognitive rehabilitation programs have been developed to improve the cognitive functions of the elderly or patients with cognitive impairments. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
Primary Outcome Measure Information:
Title
Change from baseline performance on Digit Span Test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It measures auditory attention span and includes forward and backward trials. The participant listens to a series of numbers and calls the sequence correctly. The sequence increases in each trial. The final score is the longest number of sequential digits that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline performance on Visual Span Test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It measures spatial attention span and includes forward and backward trials. The participant will see sequence of blocks "lit up" on a computer screen, and then repeat the sequence in order or back in order. The sequence increases in each trial. The final score is the longest number of sequential blocks that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline performance on Visual Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It measures a participant's visual sustained and selective attention. The participant will see numbers from "0" to "9" presented on a computer screen and they must click the mouse when "3" appeared. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline performance on Auditory Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It measures a participant's auditory sustained and selective attention. The participant will hear numbers from "0" to "9", and when they hear "3" they must click the mouse. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline performance on Trail Making Test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It consists of type A and type B trials. The participant should connect the numbers (1~25) as quickly as possible in type A trial, and connect the numbers (1~13) and alphabets (A~L) alternatively as quickly as possible in type B trial. The main scores produced in this test are completion time and errors. Higher score means worse performance.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline performance on Stroop test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline performance on Visual Recognition test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It measures participant's visual memory. The participant will see 15 visual patterns presented on a computer screen and recognize them immediately. The participant will be asked to recognize the 15 patterns after 20 minutes again. The main scores produced in this test are the numbers of recognized patterns in immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) at 4 weeks and 8 weeks
Description
It measures participant's verbal memory. The participant will hear 15 words and recall them immediately and after 20 minutes again. The main scores produced in this test are the numbers of recalled words of the immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.
Time Frame
baseline, 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline score on Korean Version of Geriatric Depression Test Short Form (Depression scale) at 4 weeks and 8 weeks
Description
It measures depressive symptoms of the participants. The score ranges between 0 and 15. Higher score means severe depression.
Time Frame
baseline, 4 weeks and 8 weeks
Title
Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) at 4 weeks and 8 weeks
Description
It measures brain activity during cognitive tasks to see if cognitive training affects brain function.
Time Frame
baseline, 4 weeks and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are diagnosed with mild cognitive impairment through clinical interview, neuropsychological tests and brain imaging
No history of neurologic diseases
Exclusion Criteria:
Severe cognitive problems(MMSE<10)
Other psychiatric disorder including bipolar or schizophrenic disorder
Other problems disturbing cognitive tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment
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