Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval; Behavioral: Blocked Retrieval

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention, then Active Comparator; Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.	Behavioral: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval; 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.; Behavioral: Blocked Retrieval; 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.
Other: Active Comparator, then Intervention; Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.	Behavioral: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval; 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.; Behavioral: Blocked Retrieval; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better)	1 week in each intervention condition
Feasibility (Engagement)	Number of possible sessions that participants complete in each condition (min: 0 - worse, max: 2 for Blocked and 12 for MEMI - better)	1 week in each intervention condition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free Recall of Word Forms	Number of target word forms that participants type without cueing (0=did not remember any words- worse to 16=remembered all the words - better)	1 week in each intervention condition
Cued Recall of Word Forms	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)	1 week in each intervention condition
Cued Recall of Word Meanings	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)	1 week in each intervention condition

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Spatial Contexts	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).	1 week in each intervention condition

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Emily Morrow, Ph.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): December 2, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: memory; traumatic brain injury; ecological momentary intervention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: GR018280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data collected during the pilot trial will be de-identified and made available following publication of the results to researchers who provide a methodologically sound proposal.
• IPD Sharing Time Frame: Beginning 6 months after results publication. No end date.
• IPD Sharing Access Criteria: Approval of a proposal by the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No