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Online Memory Intervention for Individuals with Traumatic Brain Injury

T

Toronto Rehabilitation Institute

Status

Enrolling

Conditions

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

Treatments

Behavioral: Educational Videos
Behavioral: Spatial Navigation Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04331392
2017-ABI-INFRA-1035

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

84 participants in 2 patient groups

Spatial navigation intervention
Experimental group
Treatment:
Behavioral: Spatial Navigation Intervention
Educational Videos
Active Comparator group
Treatment:
Behavioral: Educational Videos

Trial contacts and locations

1

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Central trial contact

Julia Rybkina, BSc, BA; Kadeen Johns, BA

Data sourced from clinicaltrials.gov

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