Serious Game-based Intervention for Mild Cognitive Impairment

Recruiting at 1 trial location

Overseen By Juhyeon Lee, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Massachusetts, Amherst

Disqualifiers: Neurological disorders, Traumatic brain injury, Dementia, Major depression, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial will test if playing Neuro-World games can help people with early memory and thinking problems by keeping their brains active and improving their memory and thinking skills.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Neuro-World Cognitive Training Games for mild cognitive impairment?

Research shows that serious games, like Neuro-World, can improve cognitive function in people with mild cognitive impairment. Studies found that similar game-based interventions led to better memory and attention, and participants found them engaging and useful. ^{1 2 3 4 5}

Is the serious game-based intervention for mild cognitive impairment safe for humans?

The studies reviewed suggest that serious games, including Neuro-World, are generally safe for use in humans with mild cognitive impairment, as they have been well-received and show good usability without reported adverse effects. ^{1 2 4 6 7}

How is the Neuro-World treatment different from other treatments for mild cognitive impairment?

Neuro-World is unique because it uses serious games, which are fun and engaging computer-based activities, to help improve cognitive function in people with mild cognitive impairment. Unlike traditional treatments, this approach leverages technology to maintain motivation and engagement, potentially offering broader benefits across different cognitive domains. ^{4 5 8 9 10}

Research Team

Sunghoon I Lee, PhD

Principal Investigator

University of Massachusetts, Amherst

Eligibility Criteria

This trial is for people over 55 with mild cognitive issues, scoring between 17 and 25 on the MoCA test. They must be able to use a computer for online games and assessments. It's not suitable for those with major depression, certain neurological conditions, severe hearing or vision loss, or significant arm impairments.

Inclusion Criteria

I am 55 years old or older.

Having a computer for online videoconferencing-based communication (necessary for online cognitive assessments)

Seventeen points or greater and smaller than twenty-six points on the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria

I have been diagnosed with dementia.

Participation in any other therapist-supervised cognitive training

Confounding neurological and psychiatric disorders

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Period

Participants self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week for 12 weeks in the home setting

12 weeks

24 phone calls (twice a week)

No-Intervention Period

Participants do not engage in any therapist-supervised cognitive therapies

12 weeks

24 phone calls (twice a week)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Neuro-World (Behavioural Intervention)

Trial Overview The study tests 'Neuro-World' cognitive training games designed to help brain function in patients with mild cognitive impairment. Participants will play these games at home and communicate via videoconferencing for assessments.

Participant Groups

Group I: Game Intervention Experimental Treatment 1 Intervention

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

Group II: No Intervention Active Control 1 Intervention

Study participants do not engage in any cognitive training.

Who Is Running the Clinical Trial?

University of Massachusetts, Amherst

Lead Sponsor

Trials

83

Recruited

3,474,000+

Rutgers, The State University of New Jersey

Collaborator

Trials

471

Recruited

81,700+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Findings from Research

Neuro-World, a set of six mobile games, allows individuals to self-assess their cognitive impairment levels, overcoming the barrier of needing trained therapists for traditional assessments.

The system can estimate Mini Mental State Examination (MMSE) scores with a high degree of accuracy (normalized root mean square error of 5.75%) and is responsive to changes in cognitive impairment over time, making it a promising tool for long-term monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Assessment of Cognitive Impairment Level Based on Serious Mobile Game Performance: An Initial Proof of Concept. Jung, HT., Daneault, JF., Lee, H., et al.[2020]

The smart aging serious game (SASG) effectively assesses cognitive profiles in individuals with amnestic mild cognitive impairment (aMCI) and shows good usability even among those less familiar with technology, based on a study involving 36 aMCI and 107 healthy control subjects.

SASG demonstrated superior ability to detect hippocampal degeneration compared to traditional cognitive assessments, outperforming the Montreal cognitive assessment test (MoCA), indicating its potential as a digital biomarker for early dementia detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of a Virtual Reality Platform for the Assessment of the Memory Decline and the Hippocampal Neural Injury in Subjects with Mild Cognitive Impairment: The Validity of Smart Aging Serious Game (SASG). Cabinio, M., Rossetto, F., Isernia, S., et al.[2020]

In a study involving 24 elderly individuals with mild cognitive impairment (MCI), those who participated in 12 sessions of cognitive rehabilitation training using the serious game Brain Talk™ showed significant improvements in cognitive function, as measured by the K-MMSE and K-MoCA assessments.

The improvements in cognitive scores were maintained even four weeks after the training, suggesting that home-based serious games can be an effective and safe intervention for enhancing cognitive abilities in older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Home Based Serious Game Training (Brain Talk™) in the Elderly With Mild Cognitive Impairment: Randomized, a Single-Blind, Controlled Trial. Lim, EH., Kim, DS., Won, YH., et al.[2023]

The COGNIPLAT cognitive training game significantly improved cognitive performance in elderly participants with mild cognitive impairment (MCI), as evidenced by notable enhancements in various cognitive tests after 24 training sessions.

Participants in the intervention group showed high engagement and completion rates, with a 91% completion rate and 100% attendance for follow-up, indicating that the platform is not only effective but also well-received and usable by the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of Cognitive Training with the COGNIPLAT Game Platform in Elderly with Mild Cognitive Impairment: Pilot Randomized Controlled Trial. Goumopoulos, C., Skikos, G., Frounta, M.[2023]

The study demonstrated that interactive video gaming using the Wii is feasible for older adults with mild cognitive impairment, with all 20 participants completing the 24-week intervention and 80% expressing high satisfaction.

While medium effect sizes suggested potential improvements in cognitive and physical functioning for the gaming group compared to health education, these results were not statistically significant, indicating the need for further research with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive video gaming compared with health education in older adults with mild cognitive impairment: a feasibility study. Hughes, TF., Flatt, JD., Fu, B., et al.[2021]

The serious game 'Kitchen and cooking' was found to be acceptable and engaging for elderly participants with mild cognitive impairment (MCI) and Alzheimer's disease (AD), based on a 1-month trial with 21 participants.

The game effectively stimulates executive functions and is suitable for both apathetic and non-apathetic patients, indicating its potential as a useful tool for cognitive training in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Kitchen and cooking,' a serious game for mild cognitive impairment and Alzheimer's disease: a pilot study. Manera, V., Petit, PD., Derreumaux, A., et al.[2020]

Serious Games (SG) are effective tools for assessing and improving cognitive and functional abilities in elderly individuals with mild cognitive impairment (MCI) and dementia, as confirmed by expert opinions gathered in a Delphi panel.

The use of SG should be personalized based on the type of game and the individual needs of the patient, with recommendations for use frequency ranging from 2 to 4 times a week, ideally under the guidance of trained caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for the Use of Serious Games in Neurodegenerative Disorders: 2016 Delphi Panel. Manera, V., Ben-Sadoun, G., Aalbers, T., et al.[2020]

The Smart Aging Serious Game (SASG) effectively differentiates between mild cognitive impairment (MCI) and vascular cognitive impairment (VCI) compared to healthy controls, demonstrating high diagnostic sensitivity and specificity with area under the curve (AUC) values greater than 0.800.

With a study involving 161 participants, SASG showed excellent classification accuracy (up to 91%) for identifying VCI and MCI, indicating its potential as a non-invasive digital tool for early cognitive assessment and personalized interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Validity of the Smart Aging Serious Game: An Innovative Tool for Digital Phenotyping of Mild Neurocognitive Disorder. Isernia, S., Cabinio, M., Di Tella, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Remote Assessment of Cognitive Impairment Level Based on Serious Mobile Game Performance: An Initial Proof of Concept. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of a Virtual Reality Platform for the Assessment of the Memory Decline and the Hippocampal Neural Injury in Subjects with Mild Cognitive Impairment: The Validity of Smart Aging Serious Game (SASG). [2020]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of Home Based Serious Game Training (Brain Talk™) in the Elderly With Mild Cognitive Impairment: Randomized, a Single-Blind, Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Doctor, Should I Use Computer Games to Prevent Dementia? [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of Cognitive Training with the COGNIPLAT Game Platform in Elderly with Mild Cognitive Impairment: Pilot Randomized Controlled Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Interactive video gaming compared with health education in older adults with mild cognitive impairment: a feasibility study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

'Kitchen and cooking,' a serious game for mild cognitive impairment and Alzheimer's disease: a pilot study. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Recommendations for the Use of Serious Games in Neurodegenerative Disorders: 2016 Delphi Panel. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Nonimmersive Brain Gaming for Older Adults With Cognitive Impairment: A Scoping Review. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Diagnostic Validity of the Smart Aging Serious Game: An Innovative Tool for Digital Phenotyping of Mild Neurocognitive Disorder. [2021]