Mild Cognitive Impairment
Conditions
Brief summary
This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment.
Detailed description
This study will be a cross-over randomized controlled trial. Fifty participants will be enrolled and randomly assigned to group A or group B. Group A will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week for 12 weeks in the home setting (i.e., intervention period). For the following 12 weeks, the participants will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period). Group B will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period). For the following 12 weeks, the participants will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week in the home setting (i.e., intervention period). All the participants in both groups will receive phone calls twice a week to 1) provide feedback on their adherence to Neuro-World cognitive training (during the intervention period) and 2) learn any significant changes in the level of their daily activities (during the no-intervention period and the intervention period).
Interventions
DEVICENeuro-World
Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention.
Sponsors
Rutgers, The State University of New Jersey
Université de Montréal
University of Massachusetts, Amherst
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Seventeen points or greater and smaller than twenty-six points on the Montreal Cognitive Assessment (MoCA) * Fifty-five years old and above * Minimal technological literacy (i.e. ability to use a tablet independently) * Having a computer for online videoconferencing-based communication (necessary for online cognitive assessments)
Exclusion criteria
* Confounding neurological and psychiatric disorders * History of traumatic brain injury * Clinically known hearing or vision impairment * Severe upper-limb motor impairments that could impact the use of mobile devices * Clinical presentations suggestive of dementia with Lewy bodies, progressive supranuclear palsy, multiple system atrophy, or vascular parkinsonism * Diagnosis of dementia * Major depression * Any significant upper-limb impairment that could affect tablet use * Participation in any other therapist-supervised cognitive training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montreal Cognitive Assessment (MoCA) | 12 weeks | MoCA scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MoCA scores was measured from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Digit Forward Span (DFS) | 12 weeks | DFS scores range between 0 and 14. Higher scores indicate better cognitive function. The change in DFS scores was measured from baseline to 12 weeks |
| Change in Digit Backward Span (DBS) | 12 weeks | DBS scores range between 0 and 14. Higher scores indicate better cognitive function. The change in DBS scores was measured from baseline to 12 weeks |
| Change in Mini-Mental State Examination (MMSE) | 12 weeks | MMSE scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MMSE scores was measured from baseline to 12 weeks |
| Change in Short Form 36 (SF-36) Mental Component Summary Score | 12 weeks | SF-36 consists of eight health domains, each scored from 0 to 100, with higher scores indicating more favorable health states. In this study, we report the Mental Component Summary (MCS) score, a norm-based composite score derived from relevant mental health domains. The MCS is standardized to a mean of 50 (SD = 10) in the general U.S. population, where higher scores reflect better mental well-being. The change in SF-36 MCS scores was measured from baseline to 12 weeks. |
| Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL) | 12 weeks | IADL scores range between 0 and 8. Higher scores indicate greater levels of performance in activities of daily living. The change in IADL scores was measured from baseline to 12 weeks |
| Change in Geriatric Depression Scale (GDS) | 12 weeks | GDS scores range between 0 and 15. Higher scores indicate more severe depression. The change in GDS scores was measured from baseline to 12 weeks |
Countries
United States
Participant flow
Recruitment details
Participants were recruited remotely across the United States and Canada through email, phone, and social media. Of the 155 individuals contacted, 41 were screened for eligibility via videoconference. Fifteen met inclusion criteria and were enrolled in the study. Three participants later discontinued participation.
Pre-assignment details
Fifteen participants were enrolled and randomized into two groups. Three participants discontinued participation during the study. No significant events such as washout or run-in periods occurred prior to group assignment. Four caregivers were enrolled to assist with technical arrangements and help manage study logistics. Two caregivers discontinued participation during the study after the participants they were assisting withdrew.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Intervention, Then Non-intervention Group A will self-administer Neuro-World cognitive training games for 30 minutes per day, twice a week, for 12 weeks in a home setting (intervention period). This will be followed by 12 weeks without any therapist-supervised cognitive therapies (non-intervention period). | 8 |
| Group B: Non-intervention, Then Intervention Group B will first complete a 12-week non-intervention period without therapist-supervised cognitive therapies. This will be followed by 12 weeks of self-administered Neuro-World cognitive training games for 30 minutes per day, twice a week, in a home setting (intervention period). | 7 |
| Caregivers Caregivers are optionally enrolled to assist with technical arrangements and help manage study logistics. No interventions are administered to the caregiver group. | 4 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| First Intervention (12 Weeks) | Withdrawal by Subject | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Group A: Intervention, Then Non-intervention | Total | Caregivers | Group B: Non-intervention, Then Intervention |
|---|---|---|---|---|
| Age, Continuous | 63.3 Years STANDARD_DEVIATION 13.2 | 62.4 Years STANDARD_DEVIATION 11.7 | 48.0 Years STANDARD_DEVIATION 19.6 | 57.8 Years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 15 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 8 Participants | 19 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 2 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 2 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 2 |
Outcome results
Primary
Change in Montreal Cognitive Assessment (MoCA)
MoCA scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MoCA scores was measured from baseline to 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Montreal Cognitive Assessment (MoCA) | -2.0 score on a scale | Standard Deviation 3.24 |
| No Intervention | Change in Montreal Cognitive Assessment (MoCA) | 2.8 score on a scale | Standard Deviation 1.88 |
Comparison: Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with interventionp-value: 0.997t-test, 1 sided
Secondary
Change in Digit Backward Span (DBS)
DBS scores range between 0 and 14. Higher scores indicate better cognitive function. The change in DBS scores was measured from baseline to 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Digit Backward Span (DBS) | -1.1 score on a scale | Standard Deviation 1.55 |
| No Intervention | Change in Digit Backward Span (DBS) | 1.4 score on a scale | Standard Deviation 1.5 |
Comparison: Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with interventionp-value: 0.995t-test, 1 sided
Secondary
Change in Digit Forward Span (DFS)
DFS scores range between 0 and 14. Higher scores indicate better cognitive function. The change in DFS scores was measured from baseline to 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Digit Forward Span (DFS) | -0.2 score on a scale | Standard Deviation 1.74 |
| No Intervention | Change in Digit Forward Span (DFS) | 0.8 score on a scale | Standard Deviation 1.96 |
Comparison: Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with interventionp-value: 0.821t-test, 1 sided
Secondary
Change in Geriatric Depression Scale (GDS)
GDS scores range between 0 and 15. Higher scores indicate more severe depression. The change in GDS scores was measured from baseline to 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Geriatric Depression Scale (GDS) | -0.8 score on a scale | Standard Deviation 1.77 |
| No Intervention | Change in Geriatric Depression Scale (GDS) | 0.2 score on a scale | Standard Deviation 0.69 |
Comparison: Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with interventionp-value: 0.076t-test, 1 sided
Secondary
Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)
IADL scores range between 0 and 8. Higher scores indicate greater levels of performance in activities of daily living. The change in IADL scores was measured from baseline to 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL) | -0.5 score on a scale | Standard Deviation 1.66 |
| No Intervention | Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL) | -0.1 score on a scale | Standard Deviation 1.04 |
p-value: 0.75t-test, 1 sided
Secondary
Change in Mini-Mental State Examination (MMSE)
MMSE scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MMSE scores was measured from baseline to 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Mini-Mental State Examination (MMSE) | 0.5 score on a scale | Standard Deviation 2.14 |
| No Intervention | Change in Mini-Mental State Examination (MMSE) | 0.5 score on a scale | Standard Deviation 1.85 |
Comparison: Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with interventionp-value: 0.5t-test, 1 sided
Secondary
Change in Short Form 36 (SF-36) Mental Component Summary Score
SF-36 consists of eight health domains, each scored from 0 to 100, with higher scores indicating more favorable health states. In this study, we report the Mental Component Summary (MCS) score, a norm-based composite score derived from relevant mental health domains. The MCS is standardized to a mean of 50 (SD = 10) in the general U.S. population, where higher scores reflect better mental well-being. The change in SF-36 MCS scores was measured from baseline to 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Game Intervention | Change in Short Form 36 (SF-36) Mental Component Summary Score | -0.3 score on a scale | Standard Deviation 5.68 |
| No Intervention | Change in Short Form 36 (SF-36) Mental Component Summary Score | 0.3 score on a scale | Standard Deviation 9.18 |
Comparison: Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with interventionp-value: 0.432t-test, 1 sided