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

N/ACompletedNCT04920123

University of Massachusetts, Amherst19 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Neuro-WorldDEVICE

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

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Massachusetts, Amherst

Amherst, Massachusetts, United States

The State University of New Jersey, Rutgers

Newark, New Jersey, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

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

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.

Data from ClinicalTrials.gov

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