Clinical trial NCT04331392: Online Memory Intervention for Individuals with Traumatic Brain Injury
Official title: Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
name: Centre for Aging and Brain Health Innovation
First posted: 2020-04-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the experimental intervention (allocentric navigation training) or the active control intervention (educational videos).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Imaging
timeFrame: Baseline and 1 week post-intervention.
measure: Change in Cognitive Map Formation Test (CMFT) (Medium transfer) performance,
timeFrame: Baseline and 1 week post-intervention.
measure: Change in Route Learning Navigation Test Battery - Different Approach Task (Medium transfer) performance.
timeFrame: Baseline and 1 week post-intervention.
measure: Change in Path Integration Task (Medium transfer) performance.
timeFrame: Baseline and 1 week post-intervention.
measure: Change in Memory Image Completion Task (MIC) (Far transfer) performance
timeFrame: Baseline and 1 week post-intervention.
measure: Change in Mnemonic Similarity Test (MST) (Far transfer) performance
timeFrame: Baseline and 1 week post-intervention.
measure: Navigational abilities (near-transfer)
timeFrame: Measured throughout the completion of the 16-week spatial navigation intervention.
measure: Change in Navigational Strategies Questionnaire score (medium transfer)
timeFrame: Baseline and 1 week post-intervention.
measure: Change in Santa Barbara Sense of Direction Scale score (medium transfer)
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Everyday Memory Questionnaire score (far transfer)
timeFrame: Baseline and 1 week post-intervention.
measure: Change in Digit Span score
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Visual Spatial Span score
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Sustained Attention to Response Test (SART) scores
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Symbol Digit Modalities Test (SDMT) score
timeFrame: Baseline and 1-week post-intervention.
measure: Change in the flanker inhibitory control and attention test score
timeFrame: Baseline and 1-week post-intervention.
measure: Change in the dimensional change card sort test score
timeFrame: Baseline and 1-week post-intervention.
measure: Change in pattern comparison processing speed test score
timeFrame: Baseline and 1-week post-intervention.
measure: Change in picture sequence memory test score
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Rey Auditory Verbal Learning Test (RAVLT) performance
timeFrame: Baseline and 1-week post-intervention.
measure: Change in Rey Visual Design Learning Test (RVDLT) performance
timeFrame: Baseline and 1-week post-intervention.
Secondary outcomes:
measure: Feasibility: Recruitment rate
timeFrame: Collected during recruitment
measure: Feasibility: Retention rate
timeFrame: Collected during recruitment and 1 week post-follow-up
measure: Feasibility: Compliance rate
timeFrame: Collected during each of the 80 session (5 sessions/week, 16 weeks)
measure: Feasibility: semi-structured interview
timeFrame: 1 week post-intervention
measure: Change in How Much Is Too Much scale score
timeFrame: At the end of each of the 16 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Robin E Green, PhD; CPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Baycrest Health Sciences
name: Asaf Gilboa, PhD
role: PRINCIPAL_INVESTIGATOR
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