- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405857
Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment
July 31, 2018 updated by: Samsung Medical Center
Effects of the Cognitive Enhancing Information & Communication Technology (ICT) Contents in Patients With Mild Cognitive Impairment
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Samsung medical center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day
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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.
Other Names:
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No Intervention: Group 2
No intervention will be administered
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline performance on Digit Span Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Change from baseline performance on Visual Span Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Change from baseline performance on Visual Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Change from baseline performance on Auditory Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Change from baseline performance on Trail Making Test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Change from baseline performance on Stroop test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Change from baseline performance on Visual Recognition test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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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.
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baseline, 4 weeks and 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline score on Korean Version of Geriatric Depression Test Short Form (Depression scale) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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It measures depressive symptoms of the participants.
The score ranges between 0 and 15.
Higher score means severe depression.
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baseline, 4 weeks and 8 weeks
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Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) at 4 weeks and 8 weeks
Time Frame: baseline, 4 weeks and 8 weeks
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It measures brain activity during cognitive tasks to see if cognitive training affects brain function.
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baseline, 4 weeks and 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yun-Hee Kim, PhD, Samsung medical center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2016
Primary Completion (Actual)
January 25, 2018
Study Completion (Actual)
April 7, 2018
Study Registration Dates
First Submitted
January 1, 2018
First Submitted That Met QC Criteria
January 14, 2018
First Posted (Actual)
January 23, 2018
Study Record Updates
Last Update Posted (Actual)
August 2, 2018
Last Update Submitted That Met QC Criteria
July 31, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-01-013-010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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