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

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

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

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Neuro-World

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juhyeon Lee, MS; Phone Number: 413-404-4732; Email: juhyeonlee@cs.umass.edu
• Study Contact Backup: Name: Hee-Tae Jung, PhD; Phone Number: 413-835-5135; Email: heetae@umass.edu

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • Recruiting
      • University of Massachusetts, Amherst
      • Contact: Sunghoon I Lee, PhD; Email: sunghoon@umass.edu
      • Contact: Hee-Tae Jung, PhD; Email: heetae@umass.edu
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Recruiting
      • The State University of New Jersey, Rutgers
      • Contact: Jean-Francois Daneault, PhD; Email: jf.daneault@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Game Intervention; Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).	Device: Neuro-World; Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention.
No Intervention: No Intervention; Study participants do not engage in any cognitive training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	MoCA scores range between 0 and 30. Higher scores indicate better cognitive function.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination (MMSE)	MMSE scores range between 0 and 30. Higher scores indicate better cognitive function.	10 minutes
Digit Forward Span (DFS)	DFS scores range between 0 and 14. Higher scores indicate better cognitive function.	5 minutes
Digit Backward Span (DBS)	DBS scores range between 0 and 14. Higher scores indicate better cognitive function.	5 minutes
Geriatric Depression Scale (GDS)	GDS scores range between 0 and 15. Higher scores indicate more severe depression.	5 minutes
Short Form 36 (SF-36)	SF-36 scores range between 0 and 100. Higher scores indicate more favorable health states.	10 minutes
Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for mild cognitive impairment patients (ADCS/MCI/ADL24)	ADCS/MCI/ADL24 scores range between 0 and 69. Higher scores indicate greater levels of performance in activities of daily living.	10 minutes

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: Rutgers, The State University of New Jersey; Université de Montréal
• Investigators: Principal Investigator: Sunghoon I Lee, PhD, University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No