Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
Primary Purpose
Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuro-World
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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
Sites / Locations
- University of Massachusetts, AmherstRecruiting
- The State University of New Jersey, RutgersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Game Intervention
No Intervention
Arm Description
Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).
Study participants do not engage in any cognitive training.
Outcomes
Primary Outcome Measures
Montreal Cognitive Assessment (MoCA)
MoCA scores range between 0 and 30. Higher scores indicate better cognitive function.
Secondary Outcome Measures
Mini-Mental State Examination (MMSE)
MMSE scores range between 0 and 30. Higher scores indicate better cognitive function.
Digit Forward Span (DFS)
DFS scores range between 0 and 14. Higher scores indicate better cognitive function.
Digit Backward Span (DBS)
DBS scores range between 0 and 14. Higher scores indicate better cognitive function.
Geriatric Depression Scale (GDS)
GDS scores range between 0 and 15. Higher scores indicate more severe depression.
Short Form 36 (SF-36)
SF-36 scores range between 0 and 100. Higher scores indicate more favorable health states.
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.
Full Information
NCT ID
NCT04920123
First Posted
June 3, 2021
Last Updated
September 27, 2023
Sponsor
University of Massachusetts, Amherst
Collaborators
Rutgers, The State University of New Jersey, Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT04920123
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
Rutgers, The State University of New Jersey, Université de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Game Intervention
Arm Type
Experimental
Arm Description
Study participants play Neuro-World 30 minutes per day, twice a week for 12 weeks in your home settings (24 times).
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Study participants do not engage in any cognitive training.
Intervention Type
Device
Intervention Name(s)
Neuro-World
Intervention Description
Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
MoCA scores range between 0 and 30. Higher scores indicate better cognitive function.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Mini-Mental State Examination (MMSE)
Description
MMSE scores range between 0 and 30. Higher scores indicate better cognitive function.
Time Frame
10 minutes
Title
Digit Forward Span (DFS)
Description
DFS scores range between 0 and 14. Higher scores indicate better cognitive function.
Time Frame
5 minutes
Title
Digit Backward Span (DBS)
Description
DBS scores range between 0 and 14. Higher scores indicate better cognitive function.
Time Frame
5 minutes
Title
Geriatric Depression Scale (GDS)
Description
GDS scores range between 0 and 15. Higher scores indicate more severe depression.
Time Frame
5 minutes
Title
Short Form 36 (SF-36)
Description
SF-36 scores range between 0 and 100. Higher scores indicate more favorable health states.
Time Frame
10 minutes
Title
Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for mild cognitive impairment patients (ADCS/MCI/ADL24)
Description
ADCS/MCI/ADL24 scores range between 0 and 69. Higher scores indicate greater levels of performance in activities of daily living.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juhyeon Lee, MS
Phone
413-404-4732
Email
juhyeonlee@cs.umass.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Tae Jung, PhD
Phone
413-835-5135
Email
heetae@umass.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunghoon I Lee, PhD
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts, Amherst
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunghoon I Lee, PhD
Email
sunghoon@umass.edu
First Name & Middle Initial & Last Name & Degree
Hee-Tae Jung, PhD
Email
heetae@umass.edu
Facility Name
The State University of New Jersey, Rutgers
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Daneault, PhD
Email
jf.daneault@rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
We'll reach out to this number within 24 hrs