Development of Ecological Momentary Intervention for Memory in Chronic Traumatic Brain Injury: A Pilot and Feasibility Study
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: Vanderbilt University Medical Center

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury  
NCT06375421  
Version Date: 04/02/24 
 
 
 
 
 
 
 
 
NCT Number: NCT06375421 
 
Title: Pilot and Feasibility of MEMI for  
Chronic Traumatic Brain Injury 
 
Document Date: April 2nd, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury  
NCT06375421  
Version Date: 04/02/24 
 
 
Table of Contents: 
 
 
1.0 
Rationale and Specific Aims 
2.0 
Inclusion/Exclusion Criteria 
3.0 
Enrollment/Randomization 
4.0 
Study Procedures 
5.0 
Reporting of Adverse Events or Unanticipated Problems involving 
Risk to Participants or Others 
6.0 
Study Withdrawal/Discontinuation 
7.0 
Statistical Considerations 
8.0 
Privacy/Confidentiality Issues 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury  
NCT06375421  
Version Date: 04/02/24 
1.0 
Rationale and Specific Aims 
 
While the barriers to community reintegration after traumatic brain injury (TBI) 
are multifactorial, memory and learning deficits are the most frequent targets for 
intervention in patients with TBI. The ability to (re)learn information is critical to 
a person's potential to benefit from therapy, to follow medical recommendations, 
to maintain positive social relationships, and to be successful at school or work. 
Yet, the last several decades have seen limited progress in developing restorative 
therapies for memory and learning deficits in this population.  
 
In the cognitive neuroscience literature, evidence has accumulated that people 
with and without brain damage learn more when the context of learning is varied 
across time and space. Yet, rehabilitation typically occurs in a constrained 
context (i.e., the same therapy room at the same time of day). In memory 
rehabilitation, each opportunity to retrieve information strengthens that 
information in the neocortex, and is thus both an opportunity for assessment and 
intervention. Increasing the contextual variance of learning opportunities (i.e., in 
the daily lives and contexts of patients) may improve the rehabilitation potential 
of patients with TBI, in addition to increasing the potential for interventions that 
extend beyond an acute timeframe for service delivery. 
 
There is critical need for technologies that move beyond the constrained therapy 
context to deliver interventions across time and space. In the proposed study, 
we focus on developing a technology-delivered system that extends the timing 
and context of memory exposures beyond current service delivery models. We 
aim to refine the technology for future use in research assessment and 
intervention contexts, with the long-term goal of improving memory care for 
individuals with TBI in their daily lives and across the lifespan. After taking into 
account feedback from real users, this system may also eventually be extended 
to other areas of TBI management and has the potential to improve both short-
term and chronic care for the millions of Americans currently living with brain 
injury-related disability. 
 
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. 
 
2.0 
Inclusion/Exclusion Criteria 
 
Inclusion criteria: 

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury  
NCT06375421  
Version Date: 04/02/24 
 
For participants with TBI: 
• Moderate-severe TBI. All participants sustained an injury of adequate effect to 
have been hospitalized. Severity is determined per the Mayo Classification 
System. 
• All participants are at least 6 months post-injury at the time of study 
enrollment and thus exhibit chronic and stable neuropsychological profiles.  
• All participants sustained their TBIs in adulthood (i.e., 18 years old or older) 
and are 60 years old or younger to limit the effects of age-related cognitive 
decline. 
 
For all participants: 
• Oral and written language skills sufficient for the study tasks. 
• 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. 
 
3.0 
Enrollment/Randomization 
 
No randomization will occur. 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). 
 
4.0 
Study Procedures 
 
The technology being tested involves receiving intermittent text messages over 
the course of a week with links to respond to memory prompts on the Gorilla 
mobile behavioral experiment webpage. 
 

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury  
NCT06375421  
Version Date: 04/02/24 
This pilot will include 40 participants: 20 with a history of chronic moderate-
severe TBI and 20 demographically-matched non-injured peers. Participation in 
the study will last two weeks for each person, with one week in each of two 
conditions: 
  
• Blocked (Active Comparator) Condition: Participants 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. 
• MEMI Spaced Rerieval (Intervention) Condition: 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. 
 
Outcome measures include: 
• Acceptability (Primary): Acceptability of Intervention Measure: At 
the end of each week, participants complete this four-item measure 
regarding the acceptability of each intervention condition. Scores range 
from 4 to 20, with higher scores indicating higher acceptability. 
• Feasibility (Primary): Session Engagement: In each condition, we 
measure the number of possible sessions that each participant completes. 
In the Blocked condition, the total number of possible sessions is two. In 
the MEMI condition, the number of possible sessions is 12. Higher number 
of sessions completed indicates better engagement and higher feasibility. 
• Efficacy (Secondary/Preliminary): Memory at 1 week: At the end 
of each week, participants complete memory tasks to assess their memory 
for the trained information. Measures include: 
o Free recall of word forms: The number of target word forms that 
participants can free type without cueing (0=did not remember any 
words- worse to 16=remembered all the words - better) 
o Cued recall of word forms: The 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) 
o Cued recall of word meanings: The number of target word 
meanings 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: 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 

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury  
NCT06375421  
Version Date: 04/02/24 
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. 
 
5.0 
Reporting of Adverse Events or Unanticipated Problems involving 
Risk to Participants or Others 
 
Although serious adverse events are unanticipated given the nature of this study, 
the PI will evaluate all participant concerns for severity, relationship to the 
research, and actions to be taken, and immediately report any serious adverse 
events or unanticipated problems involving risks to participants to the IRB. 
 
6.0 
Study Withdrawal/Discontinuation 
 
Participants are free to withdraw from the study at any time by contacting the 
PI. There is no penalty for early withdraw, and participants will receive payment 
proportional to the amount of the study completed. This is made clear during the 
informed consent process. 
 
7.0 
Statistical Considerations 
 
This phase of the study is descriptive and is designed to inform the research 
team regarding which aspects of using MEMI are challenging, or represents a 
barrier to use, for individuals with TBI. We collect preliminary pilot data on 
acceptability, feasibility, and the effects of technology-delivered spaced retrieval 
on memory in TBI. These findings will be used to refine the technology for future 
research and clinical trials. 
 
8.0 
Privacy/Confidentiality Issues 
 
Only KSP approved by the IRB will have access to research information. 
Participant survey data will be entered and stored electronically in REDCap. KSP 
will assign participants a unique subject ID associated with their identifiable 
information in REDCap. Original paper copies of any surveys will be de-identified 
and filed in a locked file cabinet. Participant contact information will be password 
protected and stored separately from research data, without any health 
information, on a secure VUMC server. Participant information collected for 
payment purposes will be stored separate from research data in a locked file 
cabinet.  
 
In order to minimize the risks of loss of privacy, all research-related 
conversations with participants will take place in private testing rooms on a 
private web conference session or phone call when data are collected remotely. 
Recordings from participant interviews will be saved with the unique subject ID 

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury  
NCT06375421  
Version Date: 04/02/24 
on a secure VUMC server. Twilio, the platform that delivers the mobile phone 
intervention, is integrated into REDCap in order to initiate and tailor the 
intervention (e.g., name, cell phone number, preferred time of day to receive 
text messages). Twilio will be used to send text messages at pre-designated 
times. Each of these messages contains a link to the secure web platform where 
participants will complete the memory task. Individual participant responses to 
the memory task are only accessible by KSP through a secure password 
protected portal.