Clinical trial NCT06375421: Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury
Official title: Development of Ecological Momentary Intervention for Memory in Chronic Traumatic Brain Injury: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
memory
ecological momentary intervention
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Acceptability
timeFrame: 1 week in each intervention condition
measure: Feasibility (Engagement)
timeFrame: 1 week in each intervention condition
Secondary outcomes:
measure: Free Recall of Word Forms
timeFrame: Baseline and 1 week in each intervention condition
measure: Cued Recall of Word Forms
timeFrame: Baseline and 1 week in each intervention condition
measure: Cued Recall of Word Meanings
timeFrame: Baseline and 1 week in each intervention condition
Other outcomes:
measure: Number of Spatial Contexts
timeFrame: 1 week in each intervention condition
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Emily Morrow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: