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

Trial Summary

What is the purpose of this trial?

Healthy aging is typically accompanied by diminished capability for learning and retrieval of high-fidelity long-term memory (LTM). The decline in these faculties is accelerated and becomes significant deficits in LTM and cognitive control functions at the level or a diagnosis of Mild Cognitive Impairment (MCI). Training with the navigation game, relative to training with control games, is expected to improve LTM performance for older adult participants. Researchers will compare two different digital interventions to assess whether they may be helpful in improving cognitive function. Participants will conduct study activities remotely (e.g., at-home): 1. Baseline Assessment. Complete a series of cognitive assessments and surveys. 2. Intervention. Engage in a digital intervention for up to 8 weeks. 3. Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment. 4. Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.

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 data supports the effectiveness of the BID LTM Digital Intervention treatment for amnesia?

Research shows that digital interventions, like computer-based rehabilitation, can improve memory and attention in patients with brain injuries. For example, using handheld computers has been effective in helping patients with memory impairments achieve their memory and organization goals. ^{1 2 3 4 5}

How is the BID LTM Digital Intervention treatment for amnesia different from other treatments?

The BID LTM Digital Intervention is unique because it uses digital technology to support memory function, potentially offering personalized reminders and aids to help with memory retrieval and execution, unlike traditional methods that may not incorporate such technology. ^{5 6 7 8 9}

Research Team

Peter E Wais, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Alertness Training Improves Spatial Bias and Functional Ability in Spatial Neglect. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of computerised rehabilitation for long-term aphasia: a case series study. [2018]

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

Brain state-dependent stimulation boosts functional recovery following stroke. [2019]

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

Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effectiveness of handheld computers for improving everyday memory functioning in patients with memory impairments after acquired brain injury. [2014]

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

Electronic Assistive Technology to Support Memory Function After Traumatic Brain Injury: A Systematic Review of Efficacy and User Perspectives. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A training apartment with a set of electronic memory aids for patients with cognitive problems. [2022]

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

Cognitive and Behavioral Digital Health Interventions for People with Traumatic Brain Injury and Their Caregivers: A Systematic Review. [2023]

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

Efficacy of Activities of Daily Living Retraining During Posttraumatic Amnesia: A Randomized Controlled Trial. [2022]