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

• ClinicalTrials.gov Identifier: NCT03401775
• Recruitment Status: Completed
• First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Sponsor: Samsung Medical Center
• Information provided by (Responsible Party): Samsung Medical Center

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 normal elderly subjects.

Condition or disease	Intervention/treatment	Phase
Aging	Other: Cognitive rehabilitation program	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Effects of the New Program for Cognitive Enhancement and Improvement in the Elderly
• Actual Study Start Date: December 23, 2015
• Actual Primary Completion Date: December 15, 2016
• Actual Study Completion Date: December 15, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group1; Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day	Other: Cognitive 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.; Other Name: Computer-aided Cognitive Rehabilitation Training System
No Intervention: Group2; No intervention will be administered

Outcome Measures

Primary Outcome Measures :

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 8weeks [ 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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Severe cognitive problems
• Other problems disturbing cognitive tests

Contacts and Locations

Locations

Korea, Republic of

Samsung Medical Center

Seoul, Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

• Principal Investigator: Yun-Hee Kim, PhD; Samsung Medical Center

More Information

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03401775
• Other Study ID Numbers: 2015-10-080-005
• First Posted: January 17, 2018
• Last Update Posted: January 17, 2018
• Last Verified: December 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samsung Medical Center:

aging, computerized cognitive training