Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment

Study Overview
=================
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.

Official Title
-----------------
Effects of the Cognitive Enhancing Information & Communication Technology (ICT) Contents in Patients With Mild Cognitive Impairment

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Other: Cognitive rehabilitation program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day | Other: Cognitive rehabilitation program<br>* 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.<br>* Other names: Computer-aided Cognitive Rehabilitation Training System;|
| No Intervention: Group 2<br>No intervention will be administered | |

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 | 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. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 

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 | It measures depressive symptoms of the participants. The score ranges between 0 and 15. Higher score means severe depression. | baseline, 4 weeks and 8 weeks | 
| 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. | baseline, 4 weeks and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild cognitive impairment, cognitive training program