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

NCT ID: NCT04920123

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2025-03-31

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).

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Game Intervention

Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).

Group Type: EXPERIMENTAL

Neuro-World

Intervention Type: DEVICE

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

No Intervention

Study participants do not engage in any cognitive training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neuro-World

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunghoon I Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Amherst

Locations

University of Massachusetts, Amherst

Amherst, Massachusetts, United States

The State University of New Jersey, Rutgers

Newark, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2585

Identifier Type: -

Identifier Source: org_study_id