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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06375421
Enrollment
40
Registered
2024-04-19
Start date
2024-04-03
Completion date
2024-12-02
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, memory, ecological momentary intervention

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.

Interventions

BEHAVIORALMEMI (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.

BEHAVIORALBlocked 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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability1 week in each intervention conditionAcceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better)
Feasibility (Engagement)1 week in each intervention conditionNumber of possible sessions that participants complete in each condition (min: 0 - worse, max: 2 for Blocked and 12 for MEMI - better)

Secondary

MeasureTime frameDescription
Free Recall of Word Forms1 week in each intervention conditionNumber of target word forms that participants type without cueing (0=did not remember any words- worse to 16=remembered all the words - better)
Cued Recall of Word Forms1 week in each intervention conditionNumber 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)
Cued Recall of Word Meanings1 week in each intervention conditionNumber 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

MeasureTime frameDescription
Number of Spatial Contexts1 week in each intervention conditionAt 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Participants With Traumatic Brain Injury (TBI)
Participants with TBI were in the chronic phrase (\>6 months post-injury). TBI severity was moderate-severe per the Mayo Classification System. Participants were 18-55 years of age to exclude developmental effects of TBI and conservatively limit the effects of age-related cognitive decline. Participants with TBI had no other neurological or cognitive disabilities aside from the qualifying injury.
20
Non-injured Comparison Participants
Comparison participants were also 18-55 years of age, had no history of neurological or cognitive disability, and were matched to the participants with TBI on age, sex, and education.
20
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
First Intervention (1 Week)Withdrawal by Subject1010

Baseline characteristics

CharacteristicParticipants With Traumatic Brain Injury (TBI)Non-injured Comparison ParticipantsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants20 Participants40 Participants
Age, Continuous41.1 years
STANDARD_DEVIATION 10.4
40.7 years
STANDARD_DEVIATION 9.8
40.9 years
STANDARD_DEVIATION 9.9
Educational Attainment14.7 years
STANDARD_DEVIATION 2.3
14.6 years
STANDARD_DEVIATION 2.3
14.6 years
STANDARD_DEVIATION 2.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants19 Participants19 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants1 Participants21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
20 Participants16 Participants36 Participants
Region of Enrollment
United States
20 participants20 participants40 participants
Sex: Female, Male
Female
10 Participants10 Participants20 Participants
Sex: Female, Male
Male
10 Participants10 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 190 / 190 / 19
other
Total, other adverse events
0 / 190 / 190 / 190 / 19
serious
Total, serious adverse events
0 / 190 / 190 / 190 / 19

Outcome results

Primary

Acceptability

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

Time frame: 1 week in each intervention condition

ArmMeasureValue (MEAN)Dispersion
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)Acceptability16.68 score on a scaleStandard Deviation 2.81
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)Acceptability17.55 score on a scaleStandard Deviation 2.18
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)Acceptability15.31 score on a scaleStandard Deviation 4.5
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)Acceptability17.25 score on a scaleStandard Deviation 2.79
Primary

Feasibility (Engagement)

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

Time frame: 1 week in each intervention condition

ArmMeasureValue (MEAN)Dispersion
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)Feasibility (Engagement)11.7 units on a scaleStandard Deviation 0.6
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)Feasibility (Engagement)11.8 units on a scaleStandard Deviation 0.4
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)Feasibility (Engagement)2 units on a scaleStandard Deviation 0
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)Feasibility (Engagement)2 units on a scaleStandard Deviation 0
Secondary

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)

Time frame: 1 week in each intervention condition

ArmMeasureValue (MEAN)Dispersion
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)Cued Recall of Word Forms8.9 score on a scaleStandard Deviation 5
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)Cued Recall of Word Forms12.1 score on a scaleStandard Deviation 4.5
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)Cued Recall of Word Forms3.6 score on a scaleStandard Deviation 3.4
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)Cued Recall of Word Forms6.8 score on a scaleStandard Deviation 4.5
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary

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)

Time frame: 1 week in each intervention condition

ArmMeasureValue (MEAN)Dispersion
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)Cued Recall of Word Meanings11.3 score on a scaleStandard Deviation 4.2
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)Cued Recall of Word Meanings13.9 score on a scaleStandard Deviation 3
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)Cued Recall of Word Meanings7.7 score on a scaleStandard Deviation 4.4
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)Cued Recall of Word Meanings10.5 score on a scaleStandard Deviation 4.6
p-value: 0.003t-test, 2 sided
p-value: 0.002t-test, 2 sided
Secondary

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)

Time frame: 1 week in each intervention condition

ArmMeasureValue (MEAN)Dispersion
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)Free Recall of Word Forms7.0 score on a scaleStandard Deviation 3.4
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)Free Recall of Word Forms10.9 score on a scaleStandard Deviation 3.5
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)Free Recall of Word Forms2.0 score on a scaleStandard Deviation 2.9
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)Free Recall of Word Forms4.0 score on a scaleStandard Deviation 3.6
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Other Pre-specified

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).

Time frame: 1 week in each intervention condition

ArmMeasureValue (MEAN)Dispersion
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)Number of Spatial Contexts2.6 number of spatial contextsStandard Deviation 1.4
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)Number of Spatial Contexts2.9 number of spatial contextsStandard Deviation 1.6
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)Number of Spatial Contexts1.4 number of spatial contextsStandard Deviation 0.5
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)Number of Spatial Contexts1.2 number of spatial contextsStandard Deviation 0.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026