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Completed

NCT Number: NCT04920123

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

This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts, Amherst, Amherst, Massachusetts, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuro-World

Device

Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention.

Primary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA)

    Time frame: 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 outcomes

  1. Change in Mini-Mental State Examination (MMSE)

    Time frame: 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

  2. Change in Digit Forward Span (DFS)

    Time frame: 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

  3. Change in Digit Backward Span (DBS)

    Time frame: 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

  4. Change in Geriatric Depression Scale (GDS)

    Time frame: 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

  5. Change in Short Form 36 (SF-36) Mental Component Summary Score

    Time frame: 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.

  6. Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • Rutgers, The State University of New Jersey
  • Université de Montréal

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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