Digital Intervention for Amnesia

Overseen By Melissa Arioli, AB

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Under 60, Neurological, Psychiatric, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if digital games can improve long-term memory and cognitive function in older adults. Researchers will compare two computer games: one focused on spatial challenges and another on word puzzles. Participants will use these games at home for up to 8 weeks and complete assessments before, immediately after, and six months following the intervention. The study seeks medically healthy older adults, particularly those with mild memory issues but no dementia, who are fluent in English and have normal vision and hearing. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance cognitive health in older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these digital interventions are safe for improving cognitive function?

Past studies have used digital tools like the BID LTM Digital Intervention to aid memory. These tools are typically easy to use and safe. Research on similar digital tools has shown that people can use them safely at home.

These studies have reported no major negative side effects. The tools are designed to be user-friendly and flexible, reducing risks. Since this trial is in a "Not Applicable" phase, it focuses on testing the tools' effectiveness in real-life settings rather than early safety concerns.

For those considering joining a clinical trial, this suggests that the digital tools being tested are expected to be safe based on previous research and the study's design. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital interventions being tested for amnesia because they offer a fresh approach to improving memory. Unlike traditional methods that might involve medications or static exercises, these interventions are delivered through interactive computer games. One game focuses on enhancing long-term memory by challenging spatial navigation skills, which could improve how we remember locations and directions. The other uses word puzzles to stimulate cognitive functions, offering a fun and engaging way to boost memory retention. By turning therapy into a game, these interventions could make memory improvement more accessible and enjoyable, potentially transforming the way we approach amnesia treatment.

What evidence suggests that this trial's digital interventions could be effective for improving cognitive function?

Research has shown that digital tools can improve thinking skills in older adults. In this trial, participants will join one of two digital interventions. One study arm involves the BID LTM Digital Intervention, a computer game with changing spatial challenges that might enhance long-term memory. Early results suggest it aids in learning and remembering information. Another study arm involves the game "Worder," which uses word puzzles to boost brain function. Both games aim to slow memory loss often associated with aging. These digital tools hold promise for maintaining mental health. ^{1 3 5 6 7}

Who Is on the Research Team?

Peter E Wais, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for older adults experiencing normal age-related memory challenges or those with mild cognitive impairment (MCI). Participants will engage in digital interventions from home and must be able to complete assessments at the start, after 8 weeks of intervention, and again six months later.

Inclusion Criteria

I am an older adult in good health, possibly with mild cognitive issues but no dementia.

Minimum of 12 years of education

English fluency: All task instructions are presented in English language text. Self-report of fluency in English is required.

Exclusion Criteria

I am younger than 60 years old.

I have been diagnosed with a brain or mental health disorder.

Regularly (one or more times per week) practicing an instrument within the last year

Timeline for a Trial Participant

Baseline Assessment

Participants complete a series of cognitive assessments and surveys

Up to 2 weeks

Remote sessions

Intervention

Participants engage in a digital intervention for up to 8 weeks

8 weeks

Remote sessions, several days a week

Post Intervention Assessment

Participants complete the same cognitive assessments and surveys as the Baseline Assessment

Up to 2 weeks

Remote sessions

Follow-Up Assessment

Six months after the intervention ends, participants complete the same cognitive assessments and surveys as the Baseline Assessment

1-2 weeks

Remote sessions

What Are the Treatments Tested in This Trial?

Interventions

• BID LTM Digital Intervention

Trial Overview The study tests two digital games designed to improve long-term memory (LTM) and cognitive control. One game focuses on navigation training while the other serves as a control. The effectiveness of these games in enhancing cognitive functions will be compared.

How Is the Trial Designed?

Group I: Long Term Memory Active Control 1 Intervention

Multi-session cognitive intervention as a computer game that presents an adaptive spatial wayfinding challenge.

Group II: Worder Active Control 1 Intervention

Multi-session cognitive intervention as a computer game that presents a word puzzle.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The digital health intervention significantly reduced spatially biased attention in patients with chronic hemispatial neglect, as evidenced by improved performance on the Posner cueing task (p=0.010, Cohen's d=0.96).

Participants also showed meaningful improvements in functional abilities, measured by the Catherine Bergego and Barthel indices (p=0.027, Cohen's d=0.24), indicating that the intervention not only helped with attention but also enhanced everyday functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alertness Training Improves Spatial Bias and Functional Ability in Spatial Neglect. Van Vleet, T., Bonato, P., Fabara, E., et al.[2020]

The TAPAT training program, designed to improve both sustained and moment-to-moment attention in patients with spatial neglect, has shown promising preliminary results in enhancing cognitive and functional outcomes, indicating its potential efficacy.

The RESPONSE trial will rigorously test TAPAT against an active control in a larger sample of 114 patients over three months, using a randomized controlled trial design to assess the long-term effects of the training on attention deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol. Vleet, TV., DeGutis, J., Dabit, S., et al.[2021]

In a case series study involving seven participants with long-standing aphasia due to a cerebrovascular accident, all individuals showed improvement in word finding after receiving home-based language therapy monitored via the Internet.

Additionally, four out of the seven participants experienced enhancements in their overall communication skills, suggesting that this therapy approach can be effective for individuals with aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computerised rehabilitation for long-term aphasia: a case series study. Mortley, J., Wade, J., Enderby, P., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06916221

NCT06916221 | BID LTM Digital Intervention in Aging Healthy aging is typically accompanied by diminished capability for learning and retrieval of high-fidelity long-term memory (LTM). The decline in these ...

2. withpower.com withpower.com/trial/phase-long-term-memory-4-2025-8784c

Digital Intervention for Amnesia · Info for Participants What data supports the effectiveness of the BID LTM Digital Intervention treatment for amnesia? Research shows that digital interventions, like computer ...

3. reporter.nih.gov reporter.nih.gov/project-details/11161638

RePORT RePORTER - National Institutes of Health (NIH) | BID LTM Digital Intervention in Aging Study, ENROLLING BY INVITATION. Core NIH ... efficacy of a psychological and behavioral intervention to promote physical ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06916221

BID LTM Digital Intervention in Aging - UCSF Clinical Trials This study is accepting new patients by invitation only. BID LTM Digital Intervention in Aging. a study on Long-Term Memory Inhibitory Control. Summary.

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06918704

NCT06918704 | BID WM Digital Intervention in Aging The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06918704

NCT06918704 | BID WM Digital Intervention in Aging The assessments will address various cognitive functions including working memory, long-term memory, inhibitory control, and sustained attention. Surveys will ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030155/

A digital health home intervention for people within the ... This study tested the efficacy of digital-health home intervention for people within the Alzheimer's disease (AD)-continuum.