Serious Game-based Intervention for Mild Cognitive Impairment

No longer recruiting at 1 trial location

Overseen By Juhyeon Lee, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Amherst

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 48

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a set of cognitive training games called Neuro-World can help people with mild cognitive impairment, which involves a decline in memory and thinking skills. Participants will either play these games at home or refrain from any cognitive training to determine if the games improve cognitive abilities. It suits those with mild cognitive issues who can use a tablet and have computer access for online sessions. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cognitive health strategies.

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 prior data suggests that this game-based intervention is safe for individuals with mild cognitive impairment?

Research shows that games like Neuro-World are generally safe for people with mild memory problems. Studies have found that these games usually do not cause harm. Designed to improve memory and focus, Neuro-World is used on a tablet. No major reports of negative effects have emerged from using these games, suggesting they are well-tolerated by users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neuro-World is unique because it uses a game-based approach to tackle mild cognitive impairment, which is different from traditional treatments like medication or cognitive therapy. This digital intervention is exciting because it can be easily accessed from home, making it more convenient for participants. Plus, by engaging users through gameplay, it may enhance motivation and adherence to the treatment, potentially leading to better cognitive outcomes. Researchers are eager to see if this fun and interactive method can provide effective cognitive benefits.

What evidence suggests that Neuro-World cognitive training games are effective for mild cognitive impairment?

Research shows that serious games, like Neuro-World, can improve thinking skills in people with mild memory problems. In this trial, participants in the Game Intervention arm will play Neuro-World for 30 minutes per day, twice a week for 12 weeks. Earlier studies demonstrated that Neuro-World improved mental abilities in people who had a stroke, suggesting it might benefit others as well. These games are designed to boost memory and focus, which are often affected by memory issues. Early results indicate that regular play can enhance memory and focus. This offers hope to those with mild memory problems who wish to maintain or improve their mental sharpness. ^{1 2 3 4 6}

Who Is on the Research Team?

Sunghoon I Lee, PhD

Principal Investigator

University of Massachusetts, Amherst

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Neuro-World

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Computerized cognitive training (CCT), including commercially available 'brain games', may lead to modest improvements in cognitive functions like episodic memory and mood in older adults with Mild Cognitive Impairment (MCI), based on a review of 15 studies.

Despite these improvements, there is no evidence that 'brain games' can prevent dementia, highlighting the need for caution when discussing their effectiveness with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doctor, Should I Use Computer Games to Prevent Dementia? O'Shea, DM., De Wit, L., Smith, GE.[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 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]

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]

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 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]

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]

A scoping review of 17 studies on electronic brain gaming interventions for older adults with mild cognitive impairment or dementia found that most studies (12 out of 17) reported improvements in cognitive outcomes, suggesting these games can be beneficial for brain health.

The interventions lasted between 4 to 24 weeks, with an average duration of 8.4 weeks, indicating that even relatively short-term engagement with brain games can have positive effects on cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonimmersive Brain Gaming for Older Adults With Cognitive Impairment: A Scoping Review. Sood, P., Kletzel, SL., Krishnan, S., et al.[2021]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04920123

Study Details | NCT04920123 | Serious Game-based ... This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment.

2. mdpi.com mdpi.com/2076-3417/10/19/6703

Effectiveness of a Serious Game for Cognitive Training in ... We aim to demonstrate the preliminary therapeutic effectiveness of Neuro-World, serious mobile games for cognitive training, in chronic stroke survivors.

3. withpower.com withpower.com/trial/phase-cognitive-dysfunction-7-2021-7fe50

Serious Game-based Intervention 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- ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/23/NCT04920123/ICF_002.pdf

Official Study Title: Towards the development of a mobile- ... The goal of this research study is 1) to study the effectiveness of routinely playing Neuro-World cognitive training games in improving your ...

5. reporter.nih.gov reporter.nih.gov/search/pe1dquBB5keE591wABgWEw/project-details/10190616

Mobile-health technology - NIH RePORTER We plan to employ a tablet-based application – namely Neuro-World – composed of six serious games designed to stimulate working memory and selective attention, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712670/

Effects of Home-Based Computerized Cognitive Training in ... The results of this study indicated that the HB-CCT performed in community-dwelling adults with MCI improved cognitive function and reduced depression levels ...