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

NCT04920123 | Completed Results DMC

• 1 other identifier: 2585
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (6)

• Change in Mini-Mental State Examination (MMSE)

  12 weeks

• Change in Digit Forward Span (DFS)

  12 weeks

• Change in Digit Backward Span (DBS)

  12 weeks

• Change in Geriatric Depression Scale (GDS)

  12 weeks

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

  12 weeks

Study Arms (2)

Game Intervention

EXPERIMENTAL

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

Device: Neuro-World

No Intervention

NO INTERVENTION

Study participants do not engage in any cognitive training.

Interventions

Neuro-World DEVICE

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

Game Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• Rutgers, The State University of New Jersey: collaborator
• Université de Montréal: collaborator

Study Sites (2)

University of Massachusetts, Amherst

Amherst, Massachusetts, 01003, United States

Location

The State University of New Jersey, Rutgers

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Juhyeon Lee
• Organization: University of Massachusetts Amherst

juhyeonlee@cs.umass.edu

413-404-4732

Study Officials

• Sunghoon I Lee, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: February 17, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)