Online Memory Intervention for Individuals with Traumatic Brain Injury

NCT04331392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-11-25

No results posted yet for this study

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.

Conditions

  • Brain Injuries, Traumatic
  • Brain Injury Traumatic Severe
  • Brain Injury Traumatic Moderate
  • Brain Injury, Chronic

Interventions

BEHAVIORAL

Spatial 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).

BEHAVIORAL

Educational 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.

Sponsors & Collaborators

  • Ontario Neurotrauma Foundation

    collaborator OTHER
  • Centre for Aging and Brain Health Innovation

    collaborator OTHER
  • Toronto Rehabilitation Institute

    lead OTHER

Principal Investigators

  • Robin E Green, PhD; CPsych · Toronto Rehabilitation Institute

  • Asaf Gilboa, PhD · Baycrest Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2026-10-30
Completion
2027-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331392 on ClinicalTrials.gov