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Clinical Trials/NCT06375421
NCT06375421
Completed
Not Applicable

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

Vanderbilt University Medical Center1 site in 1 country40 target enrollmentApril 3, 2024

Overview

Phase
Not Applicable
Intervention
MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval
Conditions
Traumatic Brain Injury
Sponsor
Vanderbilt University Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Acceptability
Status
Completed
Last Updated
3 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 3, 2024
End Date
December 2, 2024
Last Updated
3 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Morrow

Postdoctoral Research Fellow

Vanderbilt University Medical Center

Eligibility Criteria

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.

Arms & Interventions

Intervention, then Active Comparator

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

Intervention: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval

Intervention, then Active Comparator

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

Intervention: Blocked Retrieval

Active Comparator, then Intervention

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

Intervention: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval

Active Comparator, then Intervention

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

Intervention: Blocked Retrieval

Outcomes

Primary Outcomes

Acceptability

Time Frame: 1 week in each intervention condition

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

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

  • 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)

Study Sites (1)

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