Trial Outcomes & Findings for Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury (NCT NCT06375421)
NCT ID: NCT06375421
Last Updated: 2026-01-06
Results Overview
Acceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
1 week in each intervention condition
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Participants With Traumatic Brain Injury (TBI): Intervention, Then Active Comparator
Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.
|
Non-Injured Comparison Participants: Intervention, Then Active Comparator
Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.
|
Participants With Traumatic Brain Injury (TBI): Active Comparator, Then Intervention
Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.
|
Non-injured Comparison Participants: Active Comparator, Then Intervention
Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.
|
|---|---|---|---|---|
|
First Intervention (1 Week)
STARTED
|
10
|
10
|
10
|
10
|
|
First Intervention (1 Week)
COMPLETED
|
9
|
10
|
9
|
10
|
|
First Intervention (1 Week)
NOT COMPLETED
|
1
|
0
|
1
|
0
|
|
Second Intervention (1 Week)
STARTED
|
9
|
10
|
9
|
10
|
|
Second Intervention (1 Week)
COMPLETED
|
9
|
10
|
9
|
10
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Participants With Traumatic Brain Injury (TBI): Intervention, Then Active Comparator
Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.
|
Non-Injured Comparison Participants: Intervention, Then Active Comparator
Participants complete the Intervention (MEMI spaced retrieval) week, followed by the Active Comparator (blocked retrieval) week.
|
Participants With Traumatic Brain Injury (TBI): Active Comparator, Then Intervention
Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.
|
Non-injured Comparison Participants: Active Comparator, Then Intervention
Participants complete the Active Comparator (blocked retrieval) week, followed by the Intervention (MEMI spaced retrieval) week.
|
|---|---|---|---|---|
|
First Intervention (1 Week)
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Participants With Traumatic Brain Injury (TBI)
n=20 Participants
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.
|
Non-injured Comparison Participants
n=20 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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
10 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=9 Participants
|
20 Participants
n=6 Participants
|
40 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 10.4 • n=9 Participants
|
40.7 years
STANDARD_DEVIATION 9.8 • n=6 Participants
|
40.9 years
STANDARD_DEVIATION 9.9 • n=9 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
21 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
36 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=9 Participants
|
20 participants
n=6 Participants
|
40 participants
n=9 Participants
|
|
Educational Attainment
|
14.7 years
STANDARD_DEVIATION 2.3 • n=9 Participants
|
14.6 years
STANDARD_DEVIATION 2.3 • n=6 Participants
|
14.6 years
STANDARD_DEVIATION 2.3 • n=9 Participants
|
PRIMARY outcome
Timeframe: 1 week in each intervention conditionAcceptability of Intervention Measure (4 = completely disagree/not acceptable - worse, 20 = completely agree/acceptable - better)
Outcome measures
| Measure |
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)
n=19 Participants
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.
|
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)
n=20 Participants
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.
|
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)
n=19 Participants
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.
|
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)
n=20 Participants
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.
|
|---|---|---|---|---|
|
Acceptability
|
16.68 score on a scale
Standard Deviation 2.81
|
17.55 score on a scale
Standard Deviation 2.18
|
15.31 score on a scale
Standard Deviation 4.50
|
17.25 score on a scale
Standard Deviation 2.79
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)
n=19 Participants
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.
|
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)
n=20 Participants
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.
|
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)
n=19 Participants
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.
|
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)
n=20 Participants
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.
|
|---|---|---|---|---|
|
Feasibility (Engagement)
|
11.7 units on a scale
Standard Deviation 0.6
|
11.8 units on a scale
Standard Deviation 0.4
|
2 units on a scale
Standard Deviation 0
|
2 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 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)
Outcome measures
| Measure |
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)
n=19 Participants
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.
|
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)
n=20 Participants
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.
|
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)
n=19 Participants
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.
|
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)
n=20 Participants
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.
|
|---|---|---|---|---|
|
Free Recall of Word Forms
|
7.0 score on a scale
Standard Deviation 3.4
|
10.9 score on a scale
Standard Deviation 3.5
|
2.0 score on a scale
Standard Deviation 2.9
|
4.0 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 1 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)
Outcome measures
| Measure |
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)
n=19 Participants
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.
|
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)
n=20 Participants
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.
|
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)
n=19 Participants
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.
|
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)
n=20 Participants
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.
|
|---|---|---|---|---|
|
Cued Recall of Word Forms
|
8.9 score on a scale
Standard Deviation 5.0
|
12.1 score on a scale
Standard Deviation 4.5
|
3.6 score on a scale
Standard Deviation 3.4
|
6.8 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 1 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)
Outcome measures
| Measure |
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)
n=19 Participants
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.
|
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)
n=20 Participants
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.
|
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)
n=19 Participants
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.
|
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)
n=20 Participants
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.
|
|---|---|---|---|---|
|
Cued Recall of Word Meanings
|
11.3 score on a scale
Standard Deviation 4.2
|
13.9 score on a scale
Standard Deviation 3.0
|
7.7 score on a scale
Standard Deviation 4.4
|
10.5 score on a scale
Standard Deviation 4.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 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).
Outcome measures
| Measure |
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)
n=19 Participants
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.
|
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)
n=20 Participants
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.
|
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)
n=19 Participants
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.
|
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)
n=20 Participants
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.
|
|---|---|---|---|---|
|
Number of Spatial Contexts
|
2.6 number of spatial contexts
Standard Deviation 1.4
|
2.9 number of spatial contexts
Standard Deviation 1.6
|
1.4 number of spatial contexts
Standard Deviation 0.5
|
1.2 number of spatial contexts
Standard Deviation 0.4
|
Adverse Events
Participants With Traumatic Brain Injury (TBI) Completing Intervention (MEMI Spaced Retrieval)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Injured Comparison Participants Completing Intervention (MEMI Spaced Retrieval)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants With Traumatic Brain Injury (TBI) Completing Active Comparator (Blocked Retrieval)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-injured Comparison Participants Completing Active Comparator (Blocked Retrieval)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place