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| Name | Class |
|---|---|
| Rutgers, The State University of New Jersey | OTHER |
| Université de Montréal | OTHER |
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This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Game Intervention | Experimental | Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times). |
|
| No Intervention | No Intervention | Study participants do not engage in any cognitive training. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro-World | Device | Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Change in Digit Forward Span (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunghoon I Lee, PhD | University of Massachusetts, Amherst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts, Amherst | Amherst | Massachusetts | 01003 | United States | ||
| The State University of New Jersey, Rutgers |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | Caregivers | Caregivers are optionally enrolled to assist with technical arrangements and help manage study logistics. No interventions are administered to the caregiver group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (12 Weeks) |
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| ||||||||||||||||||
| Second Intervention (12 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
24 weeks
daily questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Game Intervention | Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juhyeon Lee | University of Massachusetts Amherst | 413-404-4732 | juhyeonlee@cs.umass.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2025 | Jun 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2025 | May 21, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2023 | May 19, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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
| 12 weeks |
| 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 | 12 weeks |
| 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 | 12 weeks |
| 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. | 12 weeks |
| 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 | 12 weeks |
| Newark |
| New Jersey |
| 07102 |
| United States |
| NOT COMPLETED |
|
| 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). |
| BG002 | Caregivers | Caregivers are optionally enrolled to assist with technical arrangements and help manage study logistics. No interventions are administered to the caregiver group. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | No Intervention | Study participants do not engage in any cognitive training. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Caregivers | Caregivers are optionally enrolled to assist with technical arrangements and help manage study logistics. No interventions are administered to the caregiver group. | 0 | 2 | 0 | 2 | 0 | 2 |
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