Recruiting

Memory Intervention

Sponsor:

Toronto Rehabilitation Institute

Code:

NCT04331392

Conditions

Brain Injuries, Traumatic

Brain Injury Traumatic Severe

Brain Injury Traumatic Moderate

Brain Injury, Chronic

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Spatial Navigation Intervention

Educational Videos

Study Details

Brief 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

Study ID

NCT04331392

Start date

Oct 30, 2018

Status verified date

Nov, 2024

Completion date

Feb, 2027

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spatial navigation intervention

active comparator: Educational Videos

Interventions

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).

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.

Primary outcome measure

  • Imaging [ Time Frame: Baseline and 1 week post-intervention. ]
  • Change in Cognitive Map Formation Test (CMFT) (Medium transfer) performance, [ Time Frame: Baseline and 1 week post-intervention. ]
  • Change in Route Learning Navigation Test Battery - Different Approach Task (Medium transfer) performance. [ Time Frame: Baseline and 1 week post-intervention. ]
  • Change in Path Integration Task (Medium transfer) performance. [ Time Frame: Baseline and 1 week post-intervention. ]
  • Change in Memory Image Completion Task (MIC) (Far transfer) performance [ Time Frame: Baseline and 1 week post-intervention. ]
  • Change in Mnemonic Similarity Test (MST) (Far transfer) performance [ Time Frame: Baseline and 1 week post-intervention. ]
  • Navigational abilities (near-transfer) [ Time Frame: Measured throughout the completion of the 16-week spatial navigation intervention. ]
  • Change in Navigational Strategies Questionnaire score (medium transfer) [ Time Frame: Baseline and 1 week post-intervention. ]
  • Change in Santa Barbara Sense of Direction Scale score (medium transfer) [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Everyday Memory Questionnaire score (far transfer) [ Time Frame: Baseline and 1 week post-intervention. ]
  • Change in Digit Span score [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Visual Spatial Span score [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Sustained Attention to Response Test (SART) scores [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Symbol Digit Modalities Test (SDMT) score [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in the flanker inhibitory control and attention test score [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in the dimensional change card sort test score [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in pattern comparison processing speed test score [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in picture sequence memory test score [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Rey Auditory Verbal Learning Test (RAVLT) performance [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Rey Visual Design Learning Test (RVDLT) performance [ Time Frame: Baseline and 1-week post-intervention. ]

Central Contacts and Locations

Central contacts

Kadeen Johns, BA

416-597-3422kadeen.johns@uhn.ca

Julia Rybkina, BSc, BA

416-597-3422Remote.Enrichment@uhn.ca

Locations

Toronto Rehabilitation Institute

Recruiting

Toronto, Ontario, Canada, M5G 2A2

More Information

Sponsor

Toronto Rehabilitation Institute

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Keywords

  • Environmental enrichment
  • spatial navigation
  • traumatic brain injury
  • neurorehabilitation
  • telerehabilitation
  • hippocampus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toronto Rehabilitation Institute on 2024-11-25.