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Completed

NCT Number: NCT06375421

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

Deficits in memory and learning are hallmark to traumatic brain injury (TBI) and limit a person's ability to participate in medical care, benefit from therapy, maintain positive social relationships, and be successful at school or work. There has been limited progress in the last several decades in advancing functional memory outcomes after TBI, and constraints in the timing and context of the existing rehabilitation model may contribute. In memory rehabilitation, each opportunity to retrieve information strengthens that information in the neocortex, and is thus both an assessment and a learning opportunity. Increasing the contextual diversity of learning opportunities (i.e., in the daily lives and contexts of patients) may improve the rehabilitation potential of patients with TBI.

This study is a pilot and feasibility trial of MEMI as a technology-delivered intervention that extends memory assessment and treatment over time and space. We use a counterbalanced within-participant crossover design to examine MEMI's feasibility and acceptability in daily life and collect preliminary efficacy data as to how using MEMI in daily life affects long-term recall for participants with and without TBI. The study includes a group of adults with a chronic history of moderate-severe TBI and a demographically matched control group. Each participant uses MEMI for two weeks, each in a different condition:

  • Blocked (Active Comparator) Condition: During one of the weeks, participants will complete their initial learning session on the target words, then immediately receive all of the exposures to each of the items in a single block. They do not complete any more retrieval sessions until one week later, when they complete a 15-minute test for their memory of all of the trained items.
  • Spaced (MEMI Intervention) Condition: During the other week, participants complete their initial learning session, and the subsequent retrieval sessions are spaced out over the course of the week (two short retrieval sessions each day) using MEMI. Then, they complete a 15-minute test for their memory of all of the trained items at the end of the week.

This study addresses three aims:

Aim 1: To examine the real-world feasibility and acceptability of MEMI via user engagement and survey data.

Aim 2: To explore preliminary efficacy of spaced retrieval via MEMI to improve long-term word recall in individuals with and without chronic TBI.

Aim 3: To explore how a) spatial context and b) temporal context of exposures affect long- term word recall in people with and without chronic TBI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For participants with TBI:

  • Moderate-severe TBI. All participants were determined to have a history of moderate-severe TBI upon joining the Vanderbilt Brain Injury Patient Registry. This determination was made based on the Mayo Classification Scale.
  • All participants are at least 6 months post-injury at the time of study enrollment and thus exhibit chronic and stable neuropsychological profiles.
  • Age ranging from 18-60, to rule out developmental TBI and limit influence of age-related cognitive decline.

For all participants:

  • Oral and written language skills sufficient for the study tasks. This will be screened in the initial video conference contact with the participant, when consent is obtained.
  • Participants must own a smartphone to access the Gorilla online behavioral experiment platform from their mobile phones.

Exclusion criteria

For participants with TBI:

  • History of medical or neurological disease affecting the brain or language, before or after the qualifying TBI.

For non-injured comparison peers:

  • History of neurological or cognitive disability, including TBI

For all participants:

  • Any disability (e.g., vision impairment, hard of hearing, aphasia or other neurologic condition) that limits ability to read, type, or verbally communicate.
  • Demonstrates inability to receive and respond to a text message after training by study personnel.

Treatment and study plan

MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval

Behavioral

Participants complete their initial learning session, and the subsequent retrieval sessions are spaced out over the course of the week (two short retrieval sessions each day) using MEMI. Then, they complete a 15-minute test for their memory of all of the trained items at the end of the week.

Blocked Retrieval

Behavioral

Participants will complete their initial learning session on the target words, then immediately receive all of the exposures to each of the items in a single block. They do not complete any more retrieval sessions until one week later, when they complete a 15-minute test for their memory of all of the trained items.

Primary outcomes

  1. Acceptability

    Time frame: 1 week in each intervention condition

    Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better)

  2. Feasibility (Engagement)

    Time frame: 1 week in each intervention condition

    Number of possible sessions that participants complete in each condition (min: 0 - worse, max: 2 for Blocked and 12 for MEMI - better)

Secondary outcomes

  1. Free Recall of Word Forms

    Time frame: 1 week in each intervention condition

    Number of target word forms that participants type without cueing (0=did not remember any words- worse to 16=remembered all the words - better)

  2. Cued Recall of Word Forms

    Time frame: 1 week in each intervention condition

    Number of target word forms that participants remember in response to prompting (i.e., typing the word that labels a given image) (0=did not remember any words- worse to 16=remembered all the words - better)

  3. Cued Recall of Word Meanings

    Time frame: 1 week in each intervention condition

    Number of target word definitions that participants remember in response to prompting (i.e., typing the definition for a given word) (0=did not remember any words- worse to 16=remembered all the words - better)

Other outcomes

  1. Number of Spatial Contexts

    Time frame: 1 week in each intervention condition

    At the beginning of each retrieval session, we ask participants to give their spatial context (the physical location in which they are completing the session, e.g., home or work). We report the number of different spatial contexts in which participants completed sessions in each condition. A higher number of spatial contexts indicates more variance in the contexts of retrieval opportunities, which is a goal of this technology (better).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Development of Ecological Momentary Intervention for Memory in Chronic Traumatic Brain Injury: A Pilot and Feasibility Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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