Online Memory Intervention for Traumatic Brain Injury

Overseen By Julia Rybkina, BSc, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Toronto Rehabilitation Institute

Disqualifiers: Neurological disorder, Neurodevelopmental disorder, Systemic comorbidities, Aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program to determine if it can improve memory and brain health in individuals with moderate to severe traumatic brain injury. Participants will either engage in an online spatial navigation exercise (Spatial Navigation Intervention) or watch educational videos. The goal is to identify which option more effectively boosts memory. Suitable candidates include those diagnosed with a traumatic brain injury in a hospital, who can use a computer, and reside in the Greater Toronto Area. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance memory recovery strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this online spatial navigation intervention is safe for individuals with traumatic brain injury?

Research has shown that virtual reality (VR) treatments, such as the spatial navigation therapy under testing, are generally safe for individuals with brain injuries. Studies have found that VR can enhance memory and navigation skills without causing serious side effects.

Reviews on VR use for brain injury patients suggest that serious side effects are rare. Some individuals might experience minor issues like dizziness or headaches, but these are uncommon. The application of VR in various fields further supports its overall safety.

Although this specific therapy is still under evaluation, the use of VR in brain injury treatment has largely been positive regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Spatial Navigation Intervention for traumatic brain injury (TBI) because it takes a novel approach to improving memory function. Unlike standard treatments for TBI, which often focus on medication and physical therapy, this intervention uses online spatial navigation exercises to directly target and enhance cognitive pathways related to memory. By engaging patients in interactive, game-like tasks designed to stimulate the brain’s spatial navigation skills, this method could offer a more engaging and potentially effective way to boost memory recovery. Additionally, it provides a convenient and accessible option that can be done remotely, making it easier for patients to incorporate into their daily lives.

What evidence suggests that this online spatial navigation intervention is effective for improving memory in individuals with traumatic brain injury?

This trial will compare two interventions for traumatic brain injury (TBI): a Spatial Navigation Intervention and Educational Videos. Studies have shown that virtual reality (VR) techniques, such as the Spatial Navigation Intervention in this trial, can improve thinking skills in people with TBI. Research suggests these exercises can prevent cognitive problems in those with mild to moderate brain injuries. Virtual reality has proven useful in assessing and enhancing skills like memory and other cognitive abilities. This type of exercise uses virtual worlds to retrain the brain, helping patients navigate and remember things in real life. Overall, these findings suggest that spatial navigation exercises could effectively boost memory and brain health for those with moderate to severe TBI. ^{1 3 6 7 8}

Who Is on the Research Team?

Robin E Green, PhD; CPsych

Principal Investigator

Toronto Rehabilitation Institute

Asaf Gilboa, PhD

Principal Investigator

Baycrest Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-55 who have had a moderate to severe traumatic brain injury, confirmed by CT or MRI. Participants should be fluent in English, able to give consent (or have someone who can), and must live near Toronto for MRI access. They need basic computer skills and the ability to use at least one arm.

Inclusion Criteria

Fluency in English

I am able to understand and agree to the study, or I have someone who can legally decide for me.

Functional use of at least one upper extremity for computer use

Exclusion Criteria

I have been diagnosed with a neurodevelopmental disorder.

I have other health conditions like lupus or diabetes.

I had a traumatic brain injury before turning 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an online spatial navigation intervention or watch educational videos for 1 hour/day, 5 days a week for 16 weeks

16 weeks

Remote sessions

Follow-up

Participants are monitored for changes in memory and brain health through cognitive tests and MRI scans

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Educational Videos
• Spatial Navigation Intervention

Trial Overview The study tests an online program designed to improve memory through spatial navigation exercises versus educational videos. It aims to see if this method is effective and practical for those with traumatic brain injuries.

How Is the Trial Designed?

Group I: Spatial navigation intervention Experimental Treatment 1 Intervention

Group II: Educational Videos Active Control 1 Intervention

Who Is Running the Clinical Trial?

Toronto Rehabilitation Institute

Lead Sponsor

Trials

55

Recruited

6,000+

Ontario Neurotrauma Foundation

Collaborator

Trials

24

Recruited

1,100+

Centre for Aging and Brain Health Innovation

Collaborator

Trials

16

Recruited

5,200+

Published Research Related to This Trial

A virtual reality navigation training program was found to be highly feasible for six middle-aged stroke patients, indicating that this approach can be effectively used to improve navigation skills after brain injury.

Five out of six patients were able to learn and partially apply an alternative navigation strategy, demonstrating that navigation abilities can be modified through targeted training, which opens up new possibilities for rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation strategy training using virtual reality in six chronic stroke patients: A novel and explorative approach to the rehabilitation of navigation impairment. Claessen, MH., van der Ham, IJ., Jagersma, E., et al.[2017]

A systematic review of 13 studies involving 132 patients with traumatic brain injury (TBI) found that virtual reality (VR) interventions can significantly improve various aspects of neurocognitive performance, such as learning, memory, and attention.

While some studies showed that improvements in cognitive performance could translate to real-life activities, more research is needed to validate these findings and ensure consistent real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Virtual Reality Interventions for Improvement of Neurocognitive Performance After Traumatic Brain Injury: A Systematic Review. Manivannan, S., Al-Amri, M., Postans, M., et al.[2022]

In a study involving 24 participants (12 with traumatic brain injury and 12 matched controls), those with moderate to severe TBI exhibited significant deficits in spatial learning and memory when tested in a virtual maze environment.

The performance of TBI participants in the virtual maze correlated with their self-reported wayfinding difficulties and episodic memory scores, indicating that this virtual assessment could be a valuable tool for evaluating spatial learning deficits after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humans with traumatic brain injuries show place-learning deficits in computer-generated virtual space. Skelton, RW., Bukach, CM., Laurance, HE., et al.[2008]

A 24-year-old man with traumatic brain injury showed memory improvements after participating in a virtual navigation training program, indicating potential benefits of 3D video games in memory rehabilitation.

fMRI results revealed increased activation in the hippocampal and parahippocampal regions of the brain, suggesting that this type of training may enhance memory function by engaging key areas involved in memory processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual navigation for memory rehabilitation in a traumatic brain injured patient. Caglio, M., Latini-Corazzini, L., D'Agata, F., et al.[2012]

A study involving 11 neurologic patients with spatial disorientation and 11 healthy controls showed that a VR-based passive navigation training program significantly improved route finding abilities over five training sessions.

Both neurologic patients and healthy controls demonstrated enhanced general spatial cognition after the VR training, suggesting that this method could be effective for rehabilitating spatial deficits caused by brain damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality in neurologic rehabilitation of spatial disorientation. Kober, SE., Wood, G., Hofer, D., et al.[2021]

A novel 16-week remotely delivered intervention targeting allocentric spatial navigation is being tested on 84 participants with moderate-severe traumatic brain injury (m-sTBI) to potentially offset hippocampal atrophy and improve cognitive functions like navigation and memory.

Participants will engage in structured exploration of cities using Google Street View, with outcomes measured through cognitive assessments and MRI scans to evaluate both behavioral and neural efficacy before and after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial. Belchev, Z., Boulos, ME., Rybkina, J., et al.[2021]

Citations

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Virtual Reality for Traumatic Brain Injury - PMC In this perspective, we discuss the potential of virtual reality (VR) in the assessment and rehabilitation of traumatic brain injury.

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Online Memory Intervention for Traumatic Brain Injury This study will examine the behavioural and neurophysiological efficacy and feasibility of an online spatial navigation intervention for improving memory and ...

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Peg Forest Rehabilitation – A novel spatial navigation ... The results indicate that PFR prevents the onset of cognitive disorders following acquired a mild to moderate brain injury, and potentially other neurological ...

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Virtual reality and cognitive function rehabilitation after ... This technique has been shown to be effective in restoring CF in TBI patients, but likely lacks practical utility (return-to-work) that can be achieved through ...

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The contribution of virtual reality to the diagnosis of spatial ... Virtual reality is useful to assess large-scale navigation strategies in patients with brain injury or schizophrenia, or in the context of ageing and dementia.

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Use of Virtual Reality in Patients with Acquired Brain Injury This review will examine the studies in which virtual reality has been used as an aid, technique, or intervention in patients with acquired brain injury.

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Full article: A virtual rehabilitation tool for cognitive ... An immersive virtual reality rehabilitation tool provides clinicians with the opportunity to observe client/patients with traumatic brain injury in a practical ...

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Virtual reality for safety training: A systematic literature ... This study aims to investigate VR safety training solutions applied to various industries (excluding medical and military applications), such as construction, ...