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

University of Massachusetts, Amherst

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Device: Neuro-World

Study type: Interventional

Funder types: Other

Identifiers

NCT04920123

2585

Details and patient eligibility

About

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

Full 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).

Enrollment: 19 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Game Intervention

Experimental group

Description:

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

Treatment:

Device: Neuro-World

No Intervention

No Intervention group

Description:

Study participants do not engage in any cognitive training.