Clinical trial NCT04920123: Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: Rutgers, The State University of New Jersey
name: Université de Montréal
First posted: 2021-06-09
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 30 minutes
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: 10 minutes
measure: Digit Forward Span (DFS)
timeFrame: 5 minutes
measure: Digit Backward Span (DBS)
timeFrame: 5 minutes
measure: Geriatric Depression Scale (GDS)
timeFrame: 5 minutes
measure: Short Form 36 (SF-36)
timeFrame: 10 minutes
measure: Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for mild cognitive impairment patients (ADCS/MCI/ADL24)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts, Amherst
state: Massachusetts
city: Newark
country: United States
facility: The State University of New Jersey, Rutgers
state: New Jersey
Study officials:
affiliation: University of Massachusetts, Amherst
name: Sunghoon I Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: