Digital Interventions for Mild Cognitive Impairment

(MediDream Trial)

Recruiting in Palo Alto (17 mi)

Overseen by David Ziegler, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Antianxiety

Disqualifiers: Neurological, Psychiatric, Seizures, Glaucoma, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.

Will I have to stop taking my current medications?

You will need to stop taking anti-depressants and anti-anxiety medications to participate in this trial.

What data supports the effectiveness of the treatment MediTrain for mild cognitive impairment?

Research on similar digital interventions, like TECH and computer-based cognitive training, shows potential benefits in improving memory and cognitive functions in older adults with mild cognitive impairment. These studies suggest that digital treatments can help maintain or enhance cognitive abilities over time. ^{1 2 3 4 5}

Is the digital intervention for mild cognitive impairment safe for humans?

The safety of a cognitive-enhancing Tai Ji Quan training intervention, delivered online for older adults with mild cognitive impairment, was examined and found to be acceptable, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is the MediTrain treatment different from other treatments for mild cognitive impairment?

MediTrain is unique because it is a digital intervention specifically designed to address cognitive deficits in mild cognitive impairment (MCI) through interactive and engaging methods, unlike traditional treatments that may not focus on digital engagement. This approach leverages technology to provide cognitive training in a way that is accessible and potentially more engaging for patients. ^{1 2 4 11 12}

Research Team

David Ziegler, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for older adults who are experiencing mild cognitive impairment. Participants should be interested in testing digital interventions aimed at improving cognition, wellbeing, stress levels, and sleep quality.

Inclusion Criteria

Fluency in spoken English

I can walk easily on my own.

I am in good physical health.

Exclusion Criteria

Substance abuse

Color blindness

Magnetically-activated implant or device

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment with a novel form of closed-loop digital meditation (MediTrain) to improve cognitive abilities and sleep quality

6 months

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at immediate and 6-month follow-up

6 months

Immediate and 6-month follow-up assessments

Treatment Details

Interventions

• MediTrain (Behavioural Intervention)

Trial Overview The study is examining the effectiveness of a digital meditation program called MediTrain. It also uses wrist-worn multi-sensor watches and sleep monitors to track improvements in participants' cognitive abilities and sleep patterns.

Participant Groups

Group I: MediTrain Experimental Treatment 3 Interventions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, San Francisco San Francisco, CA

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2636

Patients Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1841

Patients Recruited

28,150,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photo-Realistic Interactive Virtual Environments for Neurorehabilitation in Mild Cognitive Impairment (NeuroVRehab.PT): A Participatory Design and Proof-of-Concept Study. Ferreira-Brito, F., Alves, S., Santos, O., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Daily Practice of Puzzle-Game Apps on Cognition in Two Groups of Older Adults: A Pre-Post Experimental Study. Givon Schaham, N., Buckman, Z., Rand, D.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Barnes, DE., Yaffe, K., Belfor, N., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. Zuschnegg, J., Schoberer, D., Häussl, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive computer-training as a therapeutic tool in Alzheimer's disease. Hofmann, M., Rösler, A., Schwarz, W., et al.[2006]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials in mild cognitive impairment: lessons for the future. Jelic, V., Kivipelto, M., Winblad, B.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an Online Virtual Falls Prevention Intervention During a Public Health Pandemic for Older Adults with Mild Cognitive Impairment: A Feasibility Trial. Li, F., Harmer, P., Voit, J., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. Kim, JH., Han, JY., Park, GC., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitively enhanced online Tai Ji Quan training intervention for community-dwelling older adults with mild cognitive impairment: A feasibility trial. Li, F., Harmer, P., Fitzgerald, K., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial. Shadyab, AH., LaCroix, AZ., Feldman, HH., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. Rosen, AC., Sugiura, L., Kramer, JH., et al.[2022]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Photo-Realistic Interactive Virtual Environments for Neurorehabilitation in Mild Cognitive Impairment (NeuroVRehab.PT): A Participatory Design and Proof-of-Concept Study. [2020]

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

The Effect of Daily Practice of Puzzle-Game Apps on Cognition in Two Groups of Older Adults: A Pre-Post Experimental Study. [2023]

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

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. [2023]

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

Interactive computer-training as a therapeutic tool in Alzheimer's disease. [2006]

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

Clinical trials in mild cognitive impairment: lessons for the future. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Implementing an Online Virtual Falls Prevention Intervention During a Public Health Pandemic for Older Adults with Mild Cognitive Impairment: A Feasibility Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A cognitively enhanced online Tai Ji Quan training intervention for community-dwelling older adults with mild cognitive impairment: A feasibility trial. [2022]

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

Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. [2022]

12. 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]