Clinical trial NCT03405857: Effects of the Cognitive Enhancing ICT Contents in Patients With Mild Cognitive Impairment
Official title: Effects of the Cognitive Enhancing Information & Communication Technology (ICT) Contents in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
cognitive training program
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline performance on Digit Span Test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline performance on Visual Span Test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline performance on Visual Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline performance on Auditory Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline performance on Trail Making Test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline performance on Stroop test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline performance on Visual Recognition test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
Secondary outcomes:
measure: Change from baseline score on Korean Version of Geriatric Depression Test Short Form (Depression scale) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
measure: Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) at 4 weeks and 8 weeks
timeFrame: baseline, 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: