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CompletedNCT03401775Updated Jan 17, 2018

Evaluation of the Effects of the New Program for Cognitive Enhancement and Improvement in the Elderly

An interventional study of Cognitive rehabilitation program in Aging, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the effect of cognitive rehabilitation program on the improvement of cognitive functions in normal elderly subjects.

Read the 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 healthy subjects with a normal cognitive function between 55 and 85 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.

02

Conditions studied

  • Aging

Keywords

  • aging, computerized cognitive training
03

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal Healthy individuals
  • No cognitive impairments
  • No history of neurologic diseases

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive problems
  • Other problems disturbing cognitive tests
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Group1

    Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day

    Other: Cognitive rehabilitation program

  • No intervention
    Group2

    No intervention will be administered

Interventions

  • OtherCognitive rehabilitation program

    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.

    Also known as: Computer-aided Cognitive Rehabilitation Training System

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 4 weeks and 8 weeks

  2. 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.

    Time frame: baseline, 4 weeks and 8 weeks

  3. 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.

    Time frame: baseline, 4 weeks and 8 weeks

  4. 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.

    Time frame: baseline, 4 weeks and 8 weeks

  5. 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.

    Time frame: baseline, 4 weeks and 8 weeks

  6. 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.

    Time frame: baseline, 4 weeks and 8 weeks

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

    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

  8. 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.

    Time frame: baseline, 4 weeks and 8 weeks

Secondary outcomes

  1. 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.

    Time frame: baseline, 4 weeks and 8 weeks

  2. 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.

    Time frame: baseline, 4 weeks and 8 weeks

06

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03401775
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Dec 23, 2015
Primary completion
Dec 15, 2016
Completion
Dec 15, 2016
Last update
Jan 17, 2018

Study contacts

Yun-Hee Kim, PhD
principal investigator · Samsung Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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