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Completed

NCT Number: NCT03405857

Effects of the Cognitive Enhancing 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).

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive rehabilitation program

Other

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: Computer-aided Cognitive Rehabilitation Training System

Primary outcomes

  1. Change from baseline performance on Digit Span Test (Neuropsychological test) at 4 weeks and 8 weeks

    Time frame: baseline, 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.

  2. Change from baseline performance on Visual Span Test (Neuropsychological test) at 4 weeks and 8 weeks

    Time frame: baseline, 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.

  3. 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

    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.

  4. 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

    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.

  5. Change from baseline performance on Trail Making Test (Neuropsychological test) at 4 weeks and 8 weeks

    Time frame: baseline, 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.

  6. Change from baseline performance on Stroop test (Neuropsychological test) at 4 weeks and 8 weeks

    Time frame: baseline, 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.

  7. Change from baseline performance on Visual Recognition test (Neuropsychological test) at 4 weeks and 8 weeks

    Time frame: baseline, 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.

  8. 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

    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 outcomes

  1. 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

    It measures depressive symptoms of the participants. The score ranges between 0 and 15. Higher score means severe depression.

  2. Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) at 4 weeks and 8 weeks

    Time frame: baseline, 4 weeks and 8 weeks

    It measures brain activity during cognitive tasks to see if cognitive training affects brain function.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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