Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Towards the Development of a Mobile-health Technology Designed to Encourage the Use of Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: Neuro-World


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Game Intervention<br>Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times). | Device: Neuro-World<br>* Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention.<br>|
| No Intervention: No Intervention<br>Study participants do not engage in any cognitive training. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) | MoCA scores range between 0 and 30. Higher scores indicate better cognitive function. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination (MMSE) | MMSE scores range between 0 and 30. Higher scores indicate better cognitive function. | 10 minutes | 
| Digit Forward Span (DFS) | DFS scores range between 0 and 14. Higher scores indicate better cognitive function. | 5 minutes | 
| Digit Backward Span (DBS) | DBS scores range between 0 and 14. Higher scores indicate better cognitive function. | 5 minutes | 
| Geriatric Depression Scale (GDS) | GDS scores range between 0 and 15. Higher scores indicate more severe depression. | 5 minutes | 
| Short Form 36 (SF-36) | SF-36 scores range between 0 and 100. Higher scores indicate more favorable health states. | 10 minutes | 
| Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for mild cognitive impairment patients (ADCS/MCI/ADL24) | ADCS/MCI/ADL24 scores range between 0 and 69. Higher scores indicate greater levels of performance in activities of daily living. | 10 minutes |