Brain Injuries, TraumaticNCT04331392
Online Memory Intervention for Individuals with Traumatic Brain Injury
A study testing Spatial Navigation Intervention and Educational Videos in people with Brain Injuries, Traumatic and Brain Injury Traumatic Severe, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Brain Injuries, Traumatic, Brain Injury Traumatic Severe, Brain Injury Traumatic Moderate
- What is being tested?
- Spatial Navigation Intervention and Educational Videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2018to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
About this study
Official title: Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled 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.
Read the detailed description
The memory impairments associated with moderate to severe traumatic brain injury can be debilitating to younger and older adults, and can prevent a person's return to work, school and social life. The "hippocampus" is a ubiquitously compromised memory brain structure in moderate-severe TBI. Unfortunately, not only does the hippocampus sustain the damage at the time of injury, but researchers have identified that it shows continued atrophy in the months and years following injury. The investigators has developed a promising behavioural intervention for arresting this shrinkage, enhancing the integrity of the hippocampus - and improving memory function. It entails engagement in novel, continuous and challenging allocentric spatial navigation, that is, learning new routes of cities, and making a map in one's head of those routes for 1 hour/day, 5 days per week for a period of 16 weeks. N=87 participants will be randomized to either the intervention group or an active control group that will watch 3 TedTalk videos per day, 5 days a week for the same duration. An MRI scan and cognitive measures focusing on memory and spatial navigation will be conducted before and after participation.
- Conditions
- Brain Injuries, Traumatic, Brain Injury Traumatic Severe, Brain Injury Traumatic Moderate, Brain Injury, Chronic
- Being tested
- Spatial Navigation Intervention, Educational Videos
- Keywords
- Environmental enrichment, spatial navigation, traumatic brain injury, neurorehabilitation, telerehabilitation, hippocampus
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injury, Chronic, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Navigation InterventionBehavioural
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 VideosBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Spatial navigation intervention | Experimental | Not described Receives: Behavioral: Spatial Navigation Intervention |
| Educational Videos | Active comparator | Not described Receives: Behavioral: Educational Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week post-intervention.
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.
Measured: Baseline and 1 week post-intervention.
Change in Route Learning Navigation Test Battery - Different Approach Task (Medium transfer) performance.
This task measures the ability to flexibly shift heading perspective.
Measured: Baseline and 1 week post-intervention.
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.
Measured: Baseline and 1 week post-intervention.
Change in Memory Image Completion Task (MIC) (Far transfer) performance
This task assesses the tendency for pattern completion processes of learned scenes.
Measured: Baseline and 1 week post-intervention.
Change in Mnemonic Similarity Test (MST) (Far transfer) performance
This task reflects mnemonic discrimination ability that requires pattern separation by testing memory performance of images of everyday objects
Measured: Baseline and 1 week post-intervention.
Navigational abilities (near-transfer)
To assess improvements to navigation-related, within-task intervention components, the following measures are collected for navigation training patients: 1) spatial learning ability based on end-of-day questions; 2) overall spatial ability improvement based on the difference in performance of end-of-week end-of-day questions, between earlier to later weeks of training; 3) independent navigation ability improvement Streetview-only reverse, alternate, and blocked routes, based on differences in performance between earlier to later weeks of training; and 4) cognitive map formation ability, based on differences in end-of-week performance between earlier and later weeks of training.
Measured: Measured throughout the completion of the 16-week spatial navigation intervention.
Change in Navigational Strategies Questionnaire score (medium transfer)
Questionnaire measuring self-reported competence in cognitive mapping of routes and large-scale environments, and the formation of survey knowledge based on allocentric or environment-centered frames of reference. Questionnaire contains 14 questions with varying answers. Each response has an answer corresponding to a map-based navigation strategy or characteristic and one corresponding to a non-map/scene-based strategy. The mapping tendency is calculated as the difference between the number of map-based answers and non-map-based answers. Some questions have a third alternative, which is not coded. Final scores range from +14 to -14; the more positive, the more map-based navigation strategies a participant uses which is the better outcome.
Measured: Baseline and 1 week post-intervention.
Change in Santa Barbara Sense of Direction Scale score (medium transfer)
Questionnaire measuring self-reported environmental spatial abilities. The responses are measured on a 7-point Likert scale (strongly agree = 1 - strongly disagree = 7), but is reversed for negative-worded questions. The final score is the average of all scores (between 1 and 7) where the higher the score, the better the perceived sense of direction. Increase in score is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in Everyday Memory Questionnaire score (far transfer)
The test comprises statements regarding forgetting things and patients indicate how frequently the examples have occurred over the prior 3 months. The response options have the following scores: Once or less in the last month=0; More than once a month but less than once a week=1; About once a week=2; More that once a week or less than once a day=3; Once or more in a day=4.
Final score for each participant is obtained by summing up all the scores from individual questions. Final score should range from 0-41, with higher the score, the better the memory. An increase in score is the better outcome.
Measured: Baseline and 1 week post-intervention.
Change in Digit Span score
The test measures verbal working memory. Participants are asked to listen to a sequence of numbers and then to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). Each correct response is worth one point; with a maximum of 14 for each subscore series and for the total score, 28. The higher the score, the better verbal working memory. An increase in score is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in Visual Spatial Span score
This task is a behavioral measure of visuospatial working memory capacity. In a sequence, the test administrator taps squares one at a time. The participant must then tap the squares in the same order that they were tapped by the administrator (for the forward variant) or in the reverse order (for backward variant). The number of boxes in the sequence increases from two at the start of the test, to nine at the end and the sequence. Each correct response is worth one point, up to a maximum of 44 points. The higher the score, the better memory. An increase in score is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in Sustained Attention to Response Test (SART) scores
This is a Go/No-Go task measuring attention where participants view a computer monitor on which a random series of single digits are presented at the regular rate of 1 per 1.15 seconds. The task is to press a single response key following each presentation with the exception of a nominated No-Go digit, to which no response should be made. Performance is measured by calculating the number of errors of commission (inappropriately responding to a No-Go stimulus), errors of omission (inappropriately failing to respond to a Go stimulus) and reaction time to Go stimuli. Higher sustained attention should result in fewer errors of commission and omission, with shorter reaction time, which is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in Symbol Digit Modalities Test (SDMT) score
The SDMT is a measure of information processing speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The score is the number of correctly coded items from 0-110 in 90 seconds, the higher the score the better the information processing speed. Higher score is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in the flanker inhibitory control and attention test score
This test measures inhibitory control and selective attention. Participants are required to indicate the left-right orientation of a centrally presented stimulus while inhibiting attention to the potentially incongruent stimuli that surround it (i.e., the flankers, typically two on either side). A composite score of accuracy and reaction time is provided; the greater the score, the better attentional capacity. An increase in this score is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in the dimensional change card sort test score
The test measures executive function. Participants sort a series of bivalent test cards, first according to one dimension (e.g., color), and then according to the other (e.g., shape), A composite score of accuracy and reaction time is provided; the greater the score, the better executive function performance reflecting high accuracy and short reaction time. Increase in score is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in pattern comparison processing speed test score
The test measures information processing speed. Participants are asked to identify whether two visual patterns are the "same" or "not the same" by pressing respective button on the keyboard. Patterns were either identical or varied on one of three dimensions: color, adding/taking something away, or one versus many. Scores reflected the number of correct items (of a possible 130) completed in 90 seconds. The greater the score, the faster the processing speed. Increase in score is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in picture sequence memory test score
The test measures episodic memory. Participant is presented with task stimuli: a sequence of pictured objects and activities related to a central theme (e.g. "working on the farm," "playing at the park,"). Participant must remember the specific order and reproduce it by placing the pictures in the correct temporal order. The score is derived from the cumulative number of adjacent pairs of pictures remembered correctly over the 3 trials. Higher score reflects better performance on task and thereby better episodic memory, which is the better outcome.
Measured: Baseline and 1-week post-intervention.
Change in Rey Auditory Verbal Learning Test (RAVLT) performance
RAVLT measures verbal memory. Test administrator reads a list of 15 words at a rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. A number of scores can be derived from the test including Immediate score (the sum of scores from 5 first trials), Learning score (the score of Trial 5 minus the score of Trial 1) and Forgetting score (the score of Trial 5 minus score of the delayed recall). The better outcomes would be increases in Immediate and Learning scores, decrease in Forgetting score.
Measured: Baseline and 1-week post-intervention.
Change in Rey Visual Design Learning Test (RVDLT) performance
RVDLT measures memory for nonverbal material. Participants are asked to memorize 15 simple visual items that are presented one by one at a rate of 2 seconds per item. Then, they are asked to draw as many test items as can be remembered. This procedure is repeated four more times. After a 15-20 minutes delay, participants are asked again to draw as many items as possible. In the Recognition phase, a set of 30 visual items containing the test items shown before and 15 items not shown before are presented in random order, participants now have identify the ones shown before in the trials. A number of scores can be derived from the test including free recall score (the sum of scores from 5 first trials), Learning score (the score of Trial 5 minus the score of Trial 1) and Delayed Recall score (the score of Trial 6, after 15-20 minute delay). The better outcome would be an increase in these scores, reflecting an improvement in memory.
Measured: Baseline and 1-week post-intervention.
Secondary outcomes (5)
Feasibility: Recruitment rate
Determined by dividing the number of patients consented by the number of eligible patients approached. Rate closer to 1 is desired.
Measured: Collected during recruitment
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.
Measured: Collected during recruitment and 1 week post-follow-up
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.
Measured: Collected during each of the 80 session (5 sessions/week, 16 weeks)
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.
Measured: 1 week post-intervention
Change in How Much Is Too Much scale score
This scale was developed by our group to quantify a patient's experience of cognitive, somatic and emotional burden in response to completing a cognitive intervention. A list of 26 symptoms will be provided, and the patient will be asked to select whether they have experienced each symptom "Less than before my session today" (=-1); "The same as before my session today" (=0); "I did not have this symptom at all today" (=0); "More than before my session today (=1); "Much more than before my session today" (=2).
By scoring each response according to the number in brackets, and averaging the numbers for all patients per symptom per week, we will evaluate whether participants experienced any particular symptom more often as a result of the intervention across the 16 weeks. Decrease in scores or maintaining a score of 0 week-to-week are the desired outcomes.
Measured: At the end of each of the 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start30 Oct 2018
- Primary completion30 Oct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the experimental intervention (allocentric navigation training) or the active control intervention (educational videos).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Centre for Aging and Brain Health Innovation
- Responsible party
- Principal investigator, Robin Green, Toronto Rehabilitation Institute
- Investigators
- Robin E Green, PhD; CPsych, Principal investigator, Toronto Rehabilitation InstituteAsaf Gilboa, PhD, Principal investigator, Baycrest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331392
- Sponsor's protocol ID
- 2017-ABI-INFRA-1035
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2020
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data will be shared that underlie the results reported in the first empirical article published on this study article, after deidentification (text, tables, figures, and appendices). Due to sensitivity of patient information and to reduce risk of identification, demographic information will be limited to age band, gender and highest education level achieved.
Publications
Corrow JC, Corrow SL, Lee E, Pancaroglu R, Burles F, Duchaine B, Iaria G, Barton JJS. Getting lost: Topographic skills in acquired and developmental prosopagnosia. Cortex. 2016 Mar;76:89-103. doi: 10.1016/j.cortex.2016.01.003. Epub 2016 Jan 22.
PubMed 26874939Wiener JM, Carroll D, Moeller S, Bibi I, Ivanova D, Allen P, Wolbers T. A novel virtual-reality-based route-learning test suite: Assessing the effects of cognitive aging on navigation. Behav Res Methods. 2020 Apr;52(2):630-640. doi: 10.3758/s13428-019-01264-8.
PubMed 31236900Persson J, Herlitz A, Engman J, Morell A, Sjolie D, Wikstrom J, Soderlund H. Remembering our origin: gender differences in spatial memory are reflected in gender differences in hippocampal lateralization. Behav Brain Res. 2013 Nov 1;256:219-28. doi: 10.1016/j.bbr.2013.07.050. Epub 2013 Aug 9.
PubMed 23938766Vieweg P, Riemer M, Berron D, Wolbers T. Memory Image Completion: Establishing a task to behaviorally assess pattern completion in humans. Hippocampus. 2019 Apr;29(4):340-351. doi: 10.1002/hipo.23030. Epub 2018 Nov 23.
PubMed 30246900Vieweg P, Stangl M, Howard LR, Wolbers T. Changes in pattern completion--a key mechanism to explain age-related recognition memory deficits? Cortex. 2015 Mar;64:343-51. doi: 10.1016/j.cortex.2014.12.007. Epub 2014 Dec 29.
PubMed 25597525Stark SM, Yassa MA, Lacy JW, Stark CE. A task to assess behavioral pattern separation (BPS) in humans: Data from healthy aging and mild cognitive impairment. Neuropsychologia. 2013 Oct;51(12):2442-9. doi: 10.1016/j.neuropsychologia.2012.12.014. Epub 2013 Jan 9.
PubMed 23313292Sunderland, A., Harris, J. E., & Baddeley, A. D. (1983). Do laboratory tests predict everyday memory? A neuropsychological study. Journal of verbal learning and verbal behavior, 22(3), 341-357.
Wiener, J., & Wolbers, T. (2018). Route Learning & Navigation Test Battery. Retrieved from osf.io/mx52y
Brunec IK, Bellana B, Ozubko JD, Man V, Robin J, Liu ZX, Grady C, Rosenbaum RS, Winocur G, Barense MD, Moscovitch M. Multiple Scales of Representation along the Hippocampal Anteroposterior Axis in Humans. Curr Biol. 2018 Jul 9;28(13):2129-2135.e6. doi: 10.1016/j.cub.2018.05.016. Epub 2018 Jun 21.
PubMed 29937352Hegarty, M., Richardson, A. E., Montello, D. R., Lovelace, K., & Subbiah, I. (2002). Development of a self-report measure of environmental spatial ability. Intelligence, 30(5), 425-448
Belchev Z, Boulos ME, Rybkina J, Johns K, Jeffay E, Colella B, Ozubko J, Bray MJC, Di Genova N, Levi A, Changoor A, Worthington T, Gilboa A, Green R. Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial. BMJ Open. 2021 Feb 11;11(2):e039767. doi: 10.1136/bmjopen-2020-039767.
PubMed 33574141
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04331392
- Acronym / sponsor ID
- 2017-ABI-INFRA-1035
- Conditions
- Brain Injuries, Traumatic, Brain Injury Traumatic Severe, Brain Injury Traumatic Moderate, Brain Injury, Chronic
- Keywords
- Environmental enrichment, spatial navigation, traumatic brain injury, neurorehabilitation, telerehabilitation, hippocampus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Centre for Aging and Brain Health Innovation
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The memory impairments associated with moderate to severe traumatic brain injury can be debilitating to younger and older adults, and can prevent a person's return to work, school and social life. The "hippocampus" is a ubiquitously compromised memory brain structure in moderate-severe TBI. Unfortunately, not only does the hippocampus sustain the damage at the time of injury, but researchers have identified that it shows continued atrophy in the months and years following injury. The investigators has developed a promising behavioural intervention for arresting this shrinkage, enhancing the integrity of the hippocampus - and improving memory function. It entails engagement in novel, continuous and challenging allocentric spatial navigation, that is, learning new routes of cities, and making a map in one's head of those routes for 1 hour/day, 5 days per week for a period of 16 weeks. N=87 participants will be randomized to either the intervention group or an active control group that will watch 3 TedTalk videos per day, 5 days a week for the same duration. An MRI scan and cognitive measures focusing on memory and spatial navigation will be conducted before and after participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the experimental intervention (allocentric navigation training) or the active control intervention (educational videos).
| Arm | Type | Receives |
|---|---|---|
| Spatial navigation intervention | Experimental | Behavioral: Spatial Navigation Intervention |
| Educational Videos | Active comparator | Behavioral: Educational Videos |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatial Navigation InterventionThe 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). | Behavioural | Spatial navigation intervention |
| Educational VideosThe 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. | Behavioural | Educational Videos |
Primary outcome
Imaging
Time frame: Baseline and 1 week post-intervention.
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.
Change in Cognitive Map Formation Test (CMFT) (Medium transfer) performance,
Time frame: Baseline and 1 week post-intervention.
This assessment measures spatial memory and navigational ability through the formation and flexible use of a mental map of a new environment.
Change in Route Learning Navigation Test Battery - Different Approach Task (Medium transfer) performance.
Time frame: Baseline and 1 week post-intervention.
This task measures the ability to flexibly shift heading perspective.
Change in Path Integration Task (Medium transfer) performance.
Time frame: Baseline and 1 week post-intervention.
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.
Change in Memory Image Completion Task (MIC) (Far transfer) performance
Time frame: Baseline and 1 week post-intervention.
This task assesses the tendency for pattern completion processes of learned scenes.
Change in Mnemonic Similarity Test (MST) (Far transfer) performance
Time frame: Baseline and 1 week post-intervention.
This task reflects mnemonic discrimination ability that requires pattern separation by testing memory performance of images of everyday objects
Navigational abilities (near-transfer)
Time frame: Measured throughout the completion of the 16-week spatial navigation intervention.
To assess improvements to navigation-related, within-task intervention components, the following measures are collected for navigation training patients: 1) spatial learning ability based on end-of-day questions; 2) overall spatial ability improvement based on the difference in performance of end-of-week end-of-day questions, between earlier to later weeks of training; 3) independent navigation ability improvement Streetview-only reverse, alternate, and blocked routes, based on differences in performance between earlier to later weeks of training; and 4) cognitive map formation ability, based on differences in end-of-week performance between earlier and later weeks of training.
Change in Navigational Strategies Questionnaire score (medium transfer)
Time frame: Baseline and 1 week post-intervention.
Questionnaire measuring self-reported competence in cognitive mapping of routes and large-scale environments, and the formation of survey knowledge based on allocentric or environment-centered frames of reference. Questionnaire contains 14 questions with varying answers. Each response has an answer corresponding to a map-based navigation strategy or characteristic and one corresponding to a non-map/scene-based strategy. The mapping tendency is calculated as the difference between the number of map-based answers and non-map-based answers. Some questions have a third alternative, which is not coded. Final scores range from +14 to -14; the more positive, the more map-based navigation strategies a participant uses which is the better outcome.
Change in Santa Barbara Sense of Direction Scale score (medium transfer)
Time frame: Baseline and 1-week post-intervention.
Questionnaire measuring self-reported environmental spatial abilities. The responses are measured on a 7-point Likert scale (strongly agree = 1 - strongly disagree = 7), but is reversed for negative-worded questions. The final score is the average of all scores (between 1 and 7) where the higher the score, the better the perceived sense of direction. Increase in score is the better outcome.
Change in Everyday Memory Questionnaire score (far transfer)
Time frame: Baseline and 1 week post-intervention.
The test comprises statements regarding forgetting things and patients indicate how frequently the examples have occurred over the prior 3 months. The response options have the following scores: Once or less in the last month=0; More than once a month but less than once a week=1; About once a week=2; More that once a week or less than once a day=3; Once or more in a day=4. Final score for each participant is obtained by summing up all the scores from individual questions. Final score should range from 0-41, with higher the score, the better the memory. An increase in score is the better outcome.
Change in Digit Span score
Time frame: Baseline and 1-week post-intervention.
The test measures verbal working memory. Participants are asked to listen to a sequence of numbers and then to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). Each correct response is worth one point; with a maximum of 14 for each subscore series and for the total score, 28. The higher the score, the better verbal working memory. An increase in score is the better outcome.
Change in Visual Spatial Span score
Time frame: Baseline and 1-week post-intervention.
This task is a behavioral measure of visuospatial working memory capacity. In a sequence, the test administrator taps squares one at a time. The participant must then tap the squares in the same order that they were tapped by the administrator (for the forward variant) or in the reverse order (for backward variant). The number of boxes in the sequence increases from two at the start of the test, to nine at the end and the sequence. Each correct response is worth one point, up to a maximum of 44 points. The higher the score, the better memory. An increase in score is the better outcome.
Change in Sustained Attention to Response Test (SART) scores
Time frame: Baseline and 1-week post-intervention.
This is a Go/No-Go task measuring attention where participants view a computer monitor on which a random series of single digits are presented at the regular rate of 1 per 1.15 seconds. The task is to press a single response key following each presentation with the exception of a nominated No-Go digit, to which no response should be made. Performance is measured by calculating the number of errors of commission (inappropriately responding to a No-Go stimulus), errors of omission (inappropriately failing to respond to a Go stimulus) and reaction time to Go stimuli. Higher sustained attention should result in fewer errors of commission and omission, with shorter reaction time, which is the better outcome.
Change in Symbol Digit Modalities Test (SDMT) score
Time frame: Baseline and 1-week post-intervention.
The SDMT is a measure of information processing speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The score is the number of correctly coded items from 0-110 in 90 seconds, the higher the score the better the information processing speed. Higher score is the better outcome.
Change in the flanker inhibitory control and attention test score
Time frame: Baseline and 1-week post-intervention.
This test measures inhibitory control and selective attention. Participants are required to indicate the left-right orientation of a centrally presented stimulus while inhibiting attention to the potentially incongruent stimuli that surround it (i.e., the flankers, typically two on either side). A composite score of accuracy and reaction time is provided; the greater the score, the better attentional capacity. An increase in this score is the better outcome.
Change in the dimensional change card sort test score
Time frame: Baseline and 1-week post-intervention.
The test measures executive function. Participants sort a series of bivalent test cards, first according to one dimension (e.g., color), and then according to the other (e.g., shape), A composite score of accuracy and reaction time is provided; the greater the score, the better executive function performance reflecting high accuracy and short reaction time. Increase in score is the better outcome.
Change in pattern comparison processing speed test score
Time frame: Baseline and 1-week post-intervention.
The test measures information processing speed. Participants are asked to identify whether two visual patterns are the "same" or "not the same" by pressing respective button on the keyboard. Patterns were either identical or varied on one of three dimensions: color, adding/taking something away, or one versus many. Scores reflected the number of correct items (of a possible 130) completed in 90 seconds. The greater the score, the faster the processing speed. Increase in score is the better outcome.
Change in picture sequence memory test score
Time frame: Baseline and 1-week post-intervention.
The test measures episodic memory. Participant is presented with task stimuli: a sequence of pictured objects and activities related to a central theme (e.g. "working on the farm," "playing at the park,"). Participant must remember the specific order and reproduce it by placing the pictures in the correct temporal order. The score is derived from the cumulative number of adjacent pairs of pictures remembered correctly over the 3 trials. Higher score reflects better performance on task and thereby better episodic memory, which is the better outcome.
Change in Rey Auditory Verbal Learning Test (RAVLT) performance
Time frame: Baseline and 1-week post-intervention.
RAVLT measures verbal memory. Test administrator reads a list of 15 words at a rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. A number of scores can be derived from the test including Immediate score (the sum of scores from 5 first trials), Learning score (the score of Trial 5 minus the score of Trial 1) and Forgetting score (the score of Trial 5 minus score of the delayed recall). The better outcomes would be increases in Immediate and Learning scores, decrease in Forgetting score.
Change in Rey Visual Design Learning Test (RVDLT) performance
Time frame: Baseline and 1-week post-intervention.
RVDLT measures memory for nonverbal material. Participants are asked to memorize 15 simple visual items that are presented one by one at a rate of 2 seconds per item. Then, they are asked to draw as many test items as can be remembered. This procedure is repeated four more times. After a 15-20 minutes delay, participants are asked again to draw as many items as possible. In the Recognition phase, a set of 30 visual items containing the test items shown before and 15 items not shown before are presented in random order, participants now have identify the ones shown before in the trials. A number of scores can be derived from the test including free recall score (the sum of scores from 5 first trials), Learning score (the score of Trial 5 minus the score of Trial 1) and Delayed Recall score (the score of Trial 6, after 15-20 minute delay). The better outcome would be an increase in these scores, reflecting an improvement in memory.
5 secondary outcomes
Feasibility: Recruitment rate
Time frame: Collected during recruitment
Feasibility: Retention rate
Time frame: Collected during recruitment and 1 week post-follow-up
Feasibility: Compliance rate
Time frame: Collected during each of the 80 session (5 sessions/week, 16 weeks)
Feasibility: semi-structured interview
Time frame: 1 week post-intervention
Change in How Much Is Too Much scale score
Time frame: At the end of each of the 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 26874939Corrow JC, Corrow SL, Lee E, Pancaroglu R, Burles F, Duchaine B, Iaria G, Barton JJS. Getting lost: Topographic skills in acquired and developmental prosopagnosia. Cortex. 2016 Mar;76:89-103. doi: 10.1016/j.cortex.2016.01.003. Epub 2016 Jan 22.
- Background: PubMed 31236900Wiener JM, Carroll D, Moeller S, Bibi I, Ivanova D, Allen P, Wolbers T. A novel virtual-reality-based route-learning test suite: Assessing the effects of cognitive aging on navigation. Behav Res Methods. 2020 Apr;52(2):630-640. doi: 10.3758/s13428-019-01264-8.
- Background: PubMed 23938766Persson J, Herlitz A, Engman J, Morell A, Sjolie D, Wikstrom J, Soderlund H. Remembering our origin: gender differences in spatial memory are reflected in gender differences in hippocampal lateralization. Behav Brain Res. 2013 Nov 1;256:219-28. doi: 10.1016/j.bbr.2013.07.050. Epub 2013 Aug 9.
- Background: PubMed 30246900Vieweg P, Riemer M, Berron D, Wolbers T. Memory Image Completion: Establishing a task to behaviorally assess pattern completion in humans. Hippocampus. 2019 Apr;29(4):340-351. doi: 10.1002/hipo.23030. Epub 2018 Nov 23.
- Background: PubMed 25597525Vieweg P, Stangl M, Howard LR, Wolbers T. Changes in pattern completion--a key mechanism to explain age-related recognition memory deficits? Cortex. 2015 Mar;64:343-51. doi: 10.1016/j.cortex.2014.12.007. Epub 2014 Dec 29.
- Background: PubMed 23313292Stark SM, Yassa MA, Lacy JW, Stark CE. A task to assess behavioral pattern separation (BPS) in humans: Data from healthy aging and mild cognitive impairment. Neuropsychologia. 2013 Oct;51(12):2442-9. doi: 10.1016/j.neuropsychologia.2012.12.014. Epub 2013 Jan 9.
- BackgroundSunderland, A., Harris, J. E., & Baddeley, A. D. (1983). Do laboratory tests predict everyday memory? A neuropsychological study. Journal of verbal learning and verbal behavior, 22(3), 341-357.
- BackgroundWiener, J., & Wolbers, T. (2018). Route Learning & Navigation Test Battery. Retrieved from osf.io/mx52y
- Background: PubMed 29937352Brunec IK, Bellana B, Ozubko JD, Man V, Robin J, Liu ZX, Grady C, Rosenbaum RS, Winocur G, Barense MD, Moscovitch M. Multiple Scales of Representation along the Hippocampal Anteroposterior Axis in Humans. Curr Biol. 2018 Jul 9;28(13):2129-2135.e6. doi: 10.1016/j.cub.2018.05.016. Epub 2018 Jun 21.
- BackgroundHegarty, M., Richardson, A. E., Montello, D. R., Lovelace, K., & Subbiah, I. (2002). Development of a self-report measure of environmental spatial ability. Intelligence, 30(5), 425-448
- Derived from this study: PubMed 33574141Belchev Z, Boulos ME, Rybkina J, Johns K, Jeffay E, Colella B, Ozubko J, Bray MJC, Di Genova N, Levi A, Changoor A, Worthington T, Gilboa A, Green R. Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial. BMJ Open. 2021 Feb 11;11(2):e039767. doi: 10.1136/bmjopen-2020-039767.
- Individual participant dataSharing planned: Yes. All individual participant data will be shared that underlie the results reported in the first empirical article published on this study article, after deidentification (text, tables, figures, and appendices). Due to sensitivity of patient information and to reduce risk of identification, demographic information will be limited to age band, gender and highest education level achieved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin E Green, PhD; CPsych principal investigator
Toronto Rehabilitation Institute
Asaf Gilboa, PhD principal investigator
Baycrest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial Navigation Intervention and Educational Videos in people with Brain Injuries, Traumatic and Brain Injury Traumatic Severe, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kadeen Johns, BA (416-597-3422 ext. 7873, kadeen.johns@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging (time frame: Baseline and 1 week post-intervention.). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331392, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.