Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury

NCT06375421 | Completed Results

• 1 other identifier: GR018280
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; memory; ecological momentary intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Free Recall of Word Forms

  1 week in each intervention condition

• Cued Recall of Word Forms

  1 week in each intervention condition

• Cued Recall of Word Meanings

  1 week in each intervention condition

Other Outcomes (1)

• Number of Spatial Contexts

  1 week in each intervention condition

Study Arms (2)

Intervention, then Active Comparator

OTHER

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

Behavioral: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval; Behavioral: Blocked Retrieval

Active Comparator, then Intervention

OTHER

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

Behavioral: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval; Behavioral: Blocked Retrieval

Interventions

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.

Active Comparator, then Intervention; Intervention, then Active Comparator

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.

Active Comparator, then Intervention; Intervention, then Active Comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Although participants were not incentivized for engagement, they were compensated for providing feedback on their experience. Participants may have been reluctant to provide critical feedback, but they were encouraged to provide their honest opinions.

Results Point of Contact

• Title: Dr. Emily Morrow
• Organization: Vanderbilt University Medical Center

emily.morrow@vumc.org

6153228392

Study Officials

• Emily Morrow, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Model Details: The order of conditions and the order of word list presentation will be counterbalanced. The order of condition/word list combination will be pre-determined, and participants will be assigned to the next available combination based on when they join the study (i.e., a counterbalanced within-person crossover design).

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 19, 2024
• Study Start: April 3, 2024
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after results publication. No end date.
• Access Criteria: Approval of a proposal by the study PI.

Locations

US (1)