Online Memory Intervention for Individuals with Traumatic Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorToronto Rehabilitation Institute

About this trial

This study will examine the behavioural and neurophysiological efficacy and feasibility of an online spatial navigation intervention for improving memory and brain health in individuals who have sustained moderate-severe traumatic brain injury.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

acute care diagnosis of m-sTBI

PTA of 24 hours or more and/or lowest GCS <13

positive CT or MRI; (4) between 18 to 55 years of age

fluency in English; (6) competency to provide informed consent or availability of a legal decision maker

Disqualifiers

neurological disorder other than TBI (e.g., dementia, stroke)

diagnosis of a neurodevelopmental disorder

TBI sustained before age 18

systemic comorbidities (e.g., lupus, diabetes)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spatial Navigation Intervention

    Behavioral

    The 16-week intervention is completed daily, 5 days/week, remotely from home on a designated study website. Each week participants learn a new city through navigation tasks which increase in difficulty day-to-day and have a total of 4 levels of difficulty, with the goal of being able to independently navigate the city by the end of the week via Google Street View. Participants complete end-of-day multiple-choice tasks, testing what they learned with 3 types of allocentric questions: 1) predicting the next street/landmark, 2) distance judgement and 3) vector mapping. Participants also complete a map placement task, which involves reporting the locations of all studied landmarks/streets. Participants are presented with auditory rewards in the forms of short audio clips about landmarks, written encouragement in the form pop-ups (e.g., "Good work, keep it up!"), and coffee card rewards based on adherence to the intervention (e.g.,$5 bi-weekly if 100% of intervention is completed).

  • Educational Videos

    Behavioral

    The 16-week active control, remote video intervention is completed daily, 5 days a week by participants on a designated website. Participants placed in the active control group are trained on educational topics by watching videos of Ted Talks, to control for the effects of generalized environmental enrichment of the same dose as targeted navigation training. For each day of training, participants are asked to select between an option of 2 possible videos, watching a total of three videos per day. To ensure compliance and sufficient attention to the videos, at the end of each video, participants are asked to rate 5 aspects of the content (relevance, interest, comprehensibility, complexity, informative), and speaker (persuasiveness, quality of delivery, facial expression, convincingness, captivation), on a scale of 1 (lowest) to 5 (highest). Additionally, as with remote navigation participants, they are given written and monetary rewards.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Spatial navigation interventionExperimental treatment 1 intervention
Group B: Educational VideosActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Imaging

Efficacy of the intervention will be measured via Magnetic Resonance Imaging (MRI) to observe structural changes to the hippocampi and the integrity of associated white matter from baseline to 1 week post-intervention.

Time frame
Baseline and 1 week post-intervention.
2

Change in Cognitive Map Formation Test (CMFT) (Medium transfer) performance,

This assessment measures spatial memory and navigational ability through the formation and flexible use of a mental map of a new environment.

Time frame
Baseline and 1 week post-intervention.
3

Change in Route Learning Navigation Test Battery - Different Approach Task (Medium transfer) performance.

This task measures the ability to flexibly shift heading perspective.

Time frame
Baseline and 1 week post-intervention.
4

Change in Path Integration Task (Medium transfer) performance.

This task also assesses the ability to flexibly shift heading perspective, as well as path integration through a series of turns initiated by the participant walking through a maze.

Time frame
Baseline and 1 week post-intervention.

Secondary outcomes

1

Feasibility: Recruitment rate

Determined by dividing the number of patients consented by the number of eligible patients approached. Rate closer to 1 is desired.

Time frame
Collected during recruitment
2

Feasibility: Retention rate

Determined by dividing the number of consented patients at baseline by the number of consented patients retained at follow-up. Factors influencing retention (e.g., medical status) will be reported as percentages. Rate closer to 1 is desired.

Time frame
Collected during recruitment and 1 week post-follow-up
3

Feasibility: Compliance rate

Determined by calculating the percentage of patients adhering to at least 80% of the training protocol. Compliance rates to be computed for individual participants weekly, and for full cohort at end of study. Rate closer to 100% is desired. Factors influencing recruitment, retention and completion will be documented and reported as percentages.

Time frame
Collected during each of the 80 session (5 sessions/week, 16 weeks)
4

Feasibility: semi-structured interview

A semi-structured interview will be administered at post-intervention assessment to ascertain experience with the intervention, and any barriers and facilitation to participation. A qualitative thematic analysis will be applied and key themes will be reported on.

Time frame
1 week post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Toronto Rehabilitation Institute

Lead sponsor

Ontario Neurotrauma Foundation

Collaborator

Centre for Aging and Brain Health Innovation

Collaborator