RecruitingNot ApplicableNCT04331392

Online Memory Intervention for Individuals with Traumatic Brain Injury

Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled Trial


Sponsor

Toronto Rehabilitation Institute

Enrollment

84 participants

Start Date

Oct 30, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria7

  • 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
  • basic computer skills (use of internet/email, mouse and arrow keys)
  • functional use of at least one upper extremity for computer use
  • resident of Greater Toronto Area (to facilitate access to the MRI).

Exclusion Criteria6

  • 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)
  • current diagnosis of aphasia
  • presence of metal inside the body (e.g., surgical clips, pacemaker) leading to ineligibility for an MRI.

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Interventions

BEHAVIORALSpatial Navigation Intervention

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).

BEHAVIORALEducational Videos

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.


Locations(1)

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

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NCT04331392


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