N/A
N=40
Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT06375421 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Acceptability — 16.68; 17.55; 15.31; 17.25 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval (Behavioral); Blocked Retrieval (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability |
16.68; 17.55; 15.31; 17.25 | — |
| PRIMARY Feasibility (Engagement) |
11.7; 11.8; 2; 2 | — |
| SECONDARY Free Recall of Word Forms |
7.0; 10.9; 2.0; 4.0 | <0.001 sig |
| SECONDARY Cued Recall of Word Forms |
8.9; 12.1; 3.6; 6.8 | <0.001 sig |
| SECONDARY Cued Recall of Word Meanings |
11.3; 13.9; 7.7; 10.5 | 0.003 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06375421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.