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

Mild Cognitive Impairment Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920123
• Other study ID #: 2585
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Amherst
• Contact: Juhyeon Lee, MS
• Phone: 413-404-4732
• Email: juhyeonlee[@]cs.umass.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	University of Massachusetts, Amherst	Amherst	Massachusetts
United States	The State University of New Jersey, Rutgers	Newark	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	Rutgers, The State University of New Jersey, Université de Montréal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment (MoCA)	MoCA scores range between 0 and 30. Higher scores indicate better cognitive function.	30 minutes
Secondary	Mini-Mental State Examination (MMSE)	MMSE scores range between 0 and 30. Higher scores indicate better cognitive function.	10 minutes
Secondary	Digit Forward Span (DFS)	DFS scores range between 0 and 14. Higher scores indicate better cognitive function.	5 minutes
Secondary	Digit Backward Span (DBS)	DBS scores range between 0 and 14. Higher scores indicate better cognitive function.	5 minutes
Secondary	Geriatric Depression Scale (GDS)	GDS scores range between 0 and 15. Higher scores indicate more severe depression.	5 minutes
Secondary	Short Form 36 (SF-36)	SF-36 scores range between 0 and 100. Higher scores indicate more favorable health states.	10 minutes
Secondary	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