Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
ID04331392

Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled Trial

Led by Toronto Rehabilitation Institute · Updated on 2024-11-25

84

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

T

Toronto Rehabilitation Institute

Lead Sponsor

O

Ontario Neurotrauma Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an online spatial navigation program designed to improve memory and brain health in people who have experienced moderate to severe traumatic brain injury (TBI). This study focuses on the hippocampus, a memory-related brain area that often suffers damage and continues to shrink after injury, potentially affecting daily functioning and quality of life. The study aims to test whether this new behavioral intervention can help stop this shrinkage and enhance memory by engaging participants in challenging navigation tasks. Participants will be randomly assigned to one of two groups for 16 weeks. The intervention group will spend about one hour a day, five days a week, learning to navigate new cities remotely using Google Street View, with tasks of increasing difficulty. They will receive auditory and written encouragement and monetary rewards for adherence. The comparison group will watch selected educational Ted Talk videos with similar frequency and will rate the videos to ensure engagement, also receiving rewards. Throughout the study, participants will complete cognitive tests focused on memory and spatial navigation before and one week after the intervention. MRI scans will be used to observe brain changes. Researchers will monitor navigational abilities during the 16 weeks and assess overall memory function and related cognitive skills. Feasibility aspects such as recruitment, retention, and compliance rates will also be tracked, including interviews after the intervention. The total involvement spans the 16-week intervention and follow-up assessments shortly after.

CONDITIONS

Brief Title

Online Memory Intervention for Individuals with Traumatic Brain Injury

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of moderate to severe traumatic brain injury confirmed by acute care
  • Post-traumatic amnesia lasting 24 hours or more and/or Glasgow Coma Scale score below 13
  • Positive CT or MRI scan confirming injury
  • Age between 18 and 55 years
  • Fluent in English
  • Able to provide informed consent or have a legal decision maker
  • Basic computer skills, including internet use, mouse, and keyboard
  • Functional use of at least one upper limb for computer operation
  • Resident of the Greater Toronto Area to allow MRI access
Not Eligible

You will not qualify if you...

  • Neurological disorders other than traumatic brain injury, such as dementia or stroke
  • Diagnosed neurodevelopmental disorders
  • Traumatic brain injury sustained before age 18
  • Systemic health conditions like lupus or diabetes
  • Current diagnosis of aphasia
  • Presence of metal implants or devices that prevent safe MRI scanning

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for MRI and cognitive assessments

Treatment

Duration - 16 weeks

Participants complete a 16-week remote intervention at home, engaging in either spatial navigation training or watching educational videos 5 days per week.

Daily sessions, 5 days per week remotely

Follow-up

Duration - 1 week

Participants complete post-intervention assessments including MRI scans and cognitive tests approximately 1 week after the intervention ends.

1 visit (in-person) for post-intervention MRI and cognitive assessments

Trial Site Locations

Total: 1 location

1

Toronto Rehabilitation Institute

Toronto, Ontario, Canada, M5G 2A2

Actively Recruiting

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Research Team

K

Kadeen Johns, BA

J

Julia Rybkina, BSc, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Remembering our origin: gender differences in spatial memory are reflected in gender differences in hippocampal lateralization.

Jonas Persson, Agneta Herlitz, Jonas Engman...

https://pubmed.ncbi.nlm.nih.gov/23938766

A task to assess behavioral pattern separation (BPS) in humans: Data from healthy aging and mild cognitive impairment.

Shauna M Stark, Michael A Yassa, Joyce W Lacy...

https://pubmed.ncbi.nlm.nih.gov/23313292

Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial.

Zorry Belchev, Mary Ellene Boulos, Julia Rybkina...

https://pubmed.ncbi.nlm.nih.gov/33574141