Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
- Conditions
- Mild Cognitive Impairment
- Interventions
- Device: Neuro-World
- Registration Number
- NCT04920123
- Lead Sponsor
- University of Massachusetts, Amherst
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Game Intervention Neuro-World Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).
- Primary Outcome Measures
Name Time Method Montreal Cognitive Assessment (MoCA) 30 minutes MoCA scores range between 0 and 30. Higher scores indicate better cognitive function.
- Secondary Outcome Measures
Name Time Method Geriatric Depression Scale (GDS) 5 minutes GDS scores range between 0 and 15. Higher scores indicate more severe depression.
Digit Forward Span (DFS) 5 minutes DFS scores range between 0 and 14. Higher scores indicate better cognitive function.
Mini-Mental State Examination (MMSE) 10 minutes MMSE scores range between 0 and 30. Higher scores indicate better cognitive function.
Short Form 36 (SF-36) 10 minutes SF-36 scores range between 0 and 100. Higher scores indicate more favorable health states.
Digit Backward Span (DBS) 5 minutes DBS scores range between 0 and 14. Higher scores indicate better cognitive function.
Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for mild cognitive impairment patients (ADCS/MCI/ADL24) 10 minutes ADCS/MCI/ADL24 scores range between 0 and 69. Higher scores indicate greater levels of performance in activities of daily living.
Trial Locations
- Locations (2)
The State University of New Jersey, Rutgers
🇺🇸Newark, New Jersey, United States
University of Massachusetts, Amherst
🇺🇸Amherst, Massachusetts, United States