MEMI App for Traumatic Brain Injury

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Neurological disease, Cognitive disability, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new mobile phone app called MEMI (Memory Ecological Momentary Intervention), designed to improve memory in individuals with chronic traumatic brain injury (TBI). The study will evaluate the app's ease of use and effectiveness for memory retrieval tasks. Participants will be divided into two groups: one will use the MEMI app first, while the other will begin with a different type of memory task. This trial suits adults who have experienced moderate to severe TBI, have been stable for at least six months, and own a smartphone. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance memory support for TBI patients.

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's best to discuss this with the study team or your doctor.

What prior data suggests that the MEMI app is safe for use in individuals with traumatic brain injury?

Research shows that MEMI, a memory aid for mobile phones, is popular among people with traumatic brain injuries. Studies found that MEMI is easy to use and well-liked by those who tried it. In these studies, no major safety issues emerged. Participants did not experience serious side effects, suggesting that the treatment is generally safe.

This information is promising, but note that the current study primarily examines the practicality and acceptability of MEMI, rather than just its safety. However, existing research suggests that MEMI is safe for adults with long-term traumatic brain injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MEMI App for Traumatic Brain Injury because it introduces a novel method called spaced retrieval to enhance memory recovery. Unlike traditional treatments that focus on generalized cognitive rehabilitation, MEMI employs ecological momentary interventions that leverage real-time, personalized memory exercises. This approach is unique because it integrates technology to provide immediate feedback and reinforcement, potentially offering more effective and timely improvements in memory function. This innovative technique aims to optimize memory retention by tailoring the timing and frequency of retrieval exercises, setting it apart from existing treatment options.

What evidence suggests that the MEMI app is effective for improving memory in individuals with traumatic brain injury?

Research shows that the MEMI app, designed for individuals with long-term brain injuries, is user-friendly and well-received. Earlier studies tested MEMI's user-friendliness and found it effective for this group. In this trial, participants will experience both the MEMI spaced retrieval intervention and an active comparator involving blocked retrieval. The app aids users in practicing memory recall at various intervals, potentially enhancing memory. Although this research remains in the early stages, initial results suggest MEMI could be a valuable tool for addressing memory issues related to brain injuries. ^{1 2 3 5 6}

Who Is on the Research Team?

Emily Morrow, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with chronic traumatic brain injury who struggle with memory issues. It aims to test a mobile phone-delivered memory support tool called MEMI. Participants should be comfortable using a smartphone and have a history of memory problems due to their condition.

Inclusion Criteria

I had a moderate to severe brain injury over 6 months ago and am between 18-60 years old.

Oral and written language skills sufficient for the study tasks, participants must own a smartphone to access the Gorilla online behavioral experiment platform from their mobile phones

Exclusion Criteria

I have a history of brain injury or cognitive disability.

I have a brain or language condition from before or after my brain injury.

Any disability that limits ability to read, type, or verbally communicate, demonstrates inability to receive and respond to a text message after training by study personnel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blocked Condition

Participants complete their initial learning session on the target words, then receive all exposures in a single block, followed by a memory test one week later.

1 week

Daily sessions (virtual)

Spaced Condition

Participants complete their initial learning session, with retrieval sessions spaced out over the week, followed by a memory test at the end of the week.

1 week

Daily sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MEMI (Memory Ecological Momentary Intervention)

Trial Overview The study is testing the effectiveness of MEMI, an app designed to help people with traumatic brain injury improve their memory through spaced retrieval exercises. The pilot will assess how easy it is to use the app and whether it's well-received by users.

How Is the Trial Designed?

Group I: Intervention, then Active Comparator Experimental Treatment 2 Interventions

Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.

Group II: Active Comparator, then Intervention Experimental Treatment 2 Interventions

Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39591513/

Development and Usability of Memory Ecological Momentary ... Conclusions: Testing MEMI with adults with chronic TBI revealed that this technology is highly usable and favorably rated for this population.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612602/

An Ecological Momentary Assessment and Intervention ... This study aimed to develop and test the usability of memory ecological momentary intervention (MEMI), a text message–based assessment and intervention tool ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06375421/pilot-and-feasibility-of-memi-for-chronic-traumatic-brain-injury?activelyRecruiting=false&page=177&id=590&slug=brain-injury

Pilot and Feasibility of MEMI for Chronic Traumatic Brain ... The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology- ...

4. researchgate.net researchgate.net/publication/386145365_An_Ecological_Momentary_Assessment_and_Intervention_Tool_for_Memory_in_Chronic_Traumatic_Brain_Injury_Development_and_Usability_of_Memory_Ecological_Momentary_Intervention

Development and Usability of Memory Ecological ... We identified a few small issues (eg, instruction wording) and made improvements between usability testing rounds. Conclusions Testing MEMI with adults with ...

5. liebertpub.com liebertpub.com/doi/abs/10.1177/08977151251359986

Ecological Momentary Assessment in Acquired Brain Injury Ecological momentary assessment (EMA) is a data collection method involving real-time, repeated sampling of behavior in the natural environment.

6. mdpi.com mdpi.com/1660-4601/18/4/2173

Use of mHealth Technology for Patient-Reported ... Outcomes included post-concussive, depressive, and affective symptoms, fatigue, daily activities, stroke risk factors, and cognitive exertion. Overall, ...