Recruiting

NeuroTrackerSpotting and Managing Adult Repeated Traumas in the Brain

Sponsor:

Université de Montréal

Code:

NCT07025317

Conditions

Brain Injury Traumatic Mild

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Perceptual-cognitive

Study Details

Brief summary:

Emerging evidence suggests that concussions (a type of mild traumatic brain injury; mTBIs) may cause chronic neurological disturbances with effects lasting beyond 20 years, changing brain structure and nearly doubling the risks of developing dementia into old age. Yet diagnoses remain notoriously difficult, gender differences are poorly understood, and negligible therapies exist to manage and treat these long-term effects.

This project proposes using a combination of NeuroTracker (a promising software-based cognitive assessment and intervention for mild TBIs), with the latest MRI techniques and blood-based biomarkers of brain function, to provide unprecedented assessment sensitivity of long-term concussion effects, comparing older male and female adults, with and without a history of concussion. Additionally, NeuroTracker will be used as a therapeutic intervention to improve outcomes in adults with histories of concussion, with the combined assessments measuring efficacy pre-post training.

This project aims to comprehensively understand the impacts of mild brain traumas into later life, via both physical and functional biomarkers of brain health. It will also validate the value of NeuroTracker as an accessible training intervention for recovering cognitive functions impacted by earlier-life concussions.

Conditions

Brain Injury Traumatic Mild

Study ID

NCT07025317

Start date

Mar 1, 2024

Status verified date

Jul, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Jul 15, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

It will be based on age (60+ years) and history of concussion (with the most recent concussion occurring at least one year prior to the study). Consistent with the literature, the history of concussion will be determined by interviewing participants about their experience with each experience of concussion (e.g. how was the injury sustained (sports injury, vehicle accident, etc.), how long has it been since the injury, did they experience a loss of consciousness during the event, how was their concussion diagnosed, what were their symptoms and when did the symptoms resolve).

The interview will also gather information on age, sex, gender, education, occupation, and medical history (e.g. mood, medications). These variables will be coded and included in analyses, as appropriate. For example, years of education and years since the most recent concussion can be used as covariates.

Exclusion Criteria:

Include the presence of a diagnosed neurological disorder (e.g. Mild Cognitive Impairment, Alzheimer's disease, Parkinson's disease), history of severe psychiatric disorder (e.g. schizophrenia), or any condition or medication that could affect cognition (e.g. psychotropic, anticholinergic drugs). Exclusion criteria also screen out the presence of any diagnosed visual impairment that could impede NeuroTracker training (i.e. severe colour blindness, monocular vision, blindness), and contraindications for MRI (e.g. metal implants).

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Control

Control lacks of perceptual-cognitive training (NeuroTracker) in individuals with and without prior mTBI.

experimental: NeuroTracker

NeuroTracker consists of perceptual-cognitive training in individuals with and without prior mTBI.

Interventions

Perceptual-cognitive

The intervention is to determine the effectiveness of NeuroTracker for treating cognitive deficits associated with a prior history of concussion. NeuroTracker has a virtual cloud-based platform (NeuroTrackerX), which has been validated for use in research. This online platform allows participants to complete the interventions from home and greatly increases the accessibility of the program. Participants will have two 30-minute training sessions per week over the course of the 6-month intervention. Each session will consist of 3 blocks of 20 trials. For each trial in a block, participants sit upright, approximately 20" away from a standard computer or laptop screen, and wear anaglyph 3D glasses while focusing on the center of a standard 20" computer screen.

Primary outcome measure

Neuropsychological cognitive assessments [ Time Frame: By the end of the second year. ]
Neuropsychological cognitive assessments [ Time Frame: By the end of the second year. ]
Neuropsychological cognitive assessments [ Time Frame: By the end of the second year. ]
Neuropsychological cognitive assessments [ Time Frame: By the end of the second year. ]
Neuropsychological cognitive assessments [ Time Frame: By the end of the second year. ]
Neuropsychological cognitive assessments [ Time Frame: By the end of the second year. ]
Multimodal biomarker assessment [ Time Frame: By the end of the second year ]
Multimodal biomarker assessment [ Time Frame: By the end of the second year ]
Multimodal biomarker assessment [ Time Frame: By the end of the second year ]
Multimodal biomarker assessment [ Time Frame: By the end of the second year ]
NeutroTracker assessement [ Time Frame: By the end of the second year ]

Central Contacts and Locations

Central contacts

Eduardo Lugo Project Manager, PhD

1-514-441-9197 eduardo.lugo.arce@umontreal.ca

Brian Christie Co-Investigator, PhD

1-250-472-4244 brain64@uvic.ca

Locations

Christie Lab

Recruiting

Victoria, British Columbia, Canada, V8N 4V3

Contacts

Brian Christie Co-Investigator, PhD

1-250-472-4244 brain64@uvic.ca

Principal Investigator:

Brian Christie Co-investigator, PhD

Jodie Gawryluk

Recruiting

Victoria, British Columbia, Canada, V8N 4V3

Contacts

Jodie Gawryluk Co-Investigator, PhD

1-250-721-7549 gawryluk@uvic.ca

1-250-721-7549

Principal Investigator:

Jodie Gawryluk Co-Investigator, PhD

Faubert Lab

Recruiting

Montreal, Quebec, Canada, H3T 1P1

Contacts

Eduardo Lugo Lab Manager, PhD

1-514-441-9197 eduardo.lugo.arce@umontreal.ca

Jocelyn Faubert Principal Investigator, PhD

1-514 343-6111 jocelyn.faubert@umontreal.ca

Principal Investigator:

Jocelyn Faubert Principal Investigator, PhD

More Information

Sponsor

Université de Montréal

Last update posted

Jul 20, 2025

Last verified

Jul, 2025

Keywords

Concussions
mild traumatic brain injury
mild brain traumas
NeuroTracker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2025-07-20.