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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot and feasibility study for a mobile phone-delivered intervention for memory, called MEMI (memory ecological momentary intervention), that was designed to support adults with chronic traumatic brain injury with their memory. The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury.

Research Team

Emily Morrow, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+