Traumatic Brain Injury
Conditions
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
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.
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 1 week in each intervention condition | Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better) |
| Feasibility (Engagement) | 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
| Measure | Time frame | Description |
|---|---|---|
| Free Recall of Word Forms | 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) |
| Cued Recall of Word Forms | 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) |
| Cued Recall of Word Meanings | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Spatial Contexts | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Intervention (1 Week) | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Participants With Traumatic Brain Injury (TBI) | Non-injured Comparison Participants | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 41.1 years STANDARD_DEVIATION 10.4 | 40.7 years STANDARD_DEVIATION 9.8 | 40.9 years STANDARD_DEVIATION 9.9 |
| Educational Attainment | 14.7 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 Participants | 19 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 1 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 16 Participants | 36 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 |
Outcome results
Acceptability
Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better)
Time frame: 1 week in each intervention condition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval) | Acceptability | 16.68 score on a scale | Standard Deviation 2.81 |
| Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval) | Acceptability | 17.55 score on a scale | Standard Deviation 2.18 |
| Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Acceptability | 15.31 score on a scale | Standard Deviation 4.5 |
| Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Acceptability | 17.25 score on a scale | Standard Deviation 2.79 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval) | Feasibility (Engagement) | 11.7 units on a scale | Standard Deviation 0.6 |
| Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval) | Feasibility (Engagement) | 11.8 units on a scale | Standard Deviation 0.4 |
| Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Feasibility (Engagement) | 2 units on a scale | Standard Deviation 0 |
| Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Feasibility (Engagement) | 2 units on a scale | Standard Deviation 0 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval) | Cued Recall of Word Forms | 8.9 score on a scale | Standard Deviation 5 |
| Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval) | Cued Recall of Word Forms | 12.1 score on a scale | Standard Deviation 4.5 |
| Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Cued Recall of Word Forms | 3.6 score on a scale | Standard Deviation 3.4 |
| Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Cued Recall of Word Forms | 6.8 score on a scale | Standard Deviation 4.5 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval) | Cued Recall of Word Meanings | 11.3 score on a scale | Standard Deviation 4.2 |
| Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval) | Cued Recall of Word Meanings | 13.9 score on a scale | Standard Deviation 3 |
| Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Cued Recall of Word Meanings | 7.7 score on a scale | Standard Deviation 4.4 |
| Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Cued Recall of Word Meanings | 10.5 score on a scale | Standard Deviation 4.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval) | Free Recall of Word Forms | 7.0 score on a scale | Standard Deviation 3.4 |
| Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval) | Free Recall of Word Forms | 10.9 score on a scale | Standard Deviation 3.5 |
| Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Free Recall of Word Forms | 2.0 score on a scale | Standard Deviation 2.9 |
| Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Free Recall of Word Forms | 4.0 score on a scale | Standard Deviation 3.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval) | Number of Spatial Contexts | 2.6 number of spatial contexts | Standard Deviation 1.4 |
| Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval) | Number of Spatial Contexts | 2.9 number of spatial contexts | Standard Deviation 1.6 |
| Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval) | Number of Spatial Contexts | 1.4 number of spatial contexts | Standard Deviation 0.5 |
| Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval) | Number of Spatial Contexts | 1.2 number of spatial contexts | Standard Deviation 0.4 |