Spotting and Managing Adult Repeated Traumas in the Brain

NCT07025317 | Recruiting

• 2 other identifiers: Projet # 2024-5858Faubert-SYN-347_NRFA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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

Keywords

Concussions; mild traumatic brain injury; mild brain traumas; NeuroTracker

Outcome Measures

Primary Outcomes (11)

• Neuropsychological cognitive assessments

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 1) the Verbal Fluency Score (number of words, standardized Z-score) as assessed by the Verbal Fluency Test (FAS \& Animals).

  By the end of the second year.

• Neuropsychological cognitive assessments

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 2) The Verbal Learning and Memory Score (the number of words recalled, standardized Z-score) as assessed by the California Verbal Learning Test - Second Edition (CVLT-II), with the alternate version used for follow-ups.

  By the end of the second year.

• Neuropsychological cognitive assessments

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 3\) The Processing Speed Score (number of correct responses, standardized Z-score) as assessed by the Symbol Digit Modalities Test.

  By the end of the second year.

• Neuropsychological cognitive assessments

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 4) The Working Memory Score (total correct sequences, standardized Z score), as assessed by the Digit Span (forward, backward, sequencing).

  By the end of the second year.

• Neuropsychological cognitive assessments

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 5) The Executive Function Score (Time in seconds, Number of errors, Standardized Z scores) as assessed by the Trail Making Test A \& B.

  By the end of the second year.

• Neuropsychological cognitive assessments

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 6) The Global Cognitive Function Score (Total score, 0-30) as evaluated by the Mini-Mental State Exam (MMSE).

  By the end of the second year.

• Multimodal biomarker assessment

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 1) the Fractional Anisotropy (FA) in A Priori ROIs (Unitless) as evaluated by Diffusion Tensor Imaging (DTI).

  By the end of the second year

• Multimodal biomarker assessment

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 2) The Mean Diffusivity in A Priori ROIs (mm2/s) as evaluated by Diffusion Tensor Imaging (DTI).

  By the end of the second year

• Multimodal biomarker assessment

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 3) The Number of Clusters With Group Differences in FA (number of clusters) as evaluated by Diffusion Tensor Imaging (DTI).

  By the end of the second year

• Multimodal biomarker assessment

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on: 4) The Number of Clusters With Group Differences in MD (number of clusters) as evaluated by Diffusion Tensor Imaging (DTI).

  By the end of the second year

• NeutroTracker assessement

  Changes from Baseline, follow-up 1 (3 months), and follow-up 2 (6 months) on the Perceptual-Cognitive Tracking Score (Speed threshold, arbitrary units) as evaluated by NeuroTracker.

  By the end of the second year

Study Arms (2)

Control

NO INTERVENTION

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

NeuroTracker

EXPERIMENTAL

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

Other: Perceptual-cognitive

Interventions

Perceptual-cognitive OTHER

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.

NeuroTracker

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead
• University of Victoria: collaborator
• NeuroTracker Athletics Inc.: collaborator
• Brain Canada: collaborator
• Consortium québécois sur la découverte du médicament: collaborator

Study Sites (3)

Christie Lab

Victoria, British Columbia, V8N 4V3, Canada

RECRUITING

Jodie Gawryluk

Victoria, British Columbia, V8N 4V3, Canada

RECRUITING

Faubert Lab

Montreal, Quebec, H3T 1P1, Canada

RECRUITING

Related Publications (13)

• Use of the wii balance board to assess changes in postural balance across athletic season HM Cullen, Y Sun, BR Christie, EP Zehr British Journal of Sports Medicine 51 (11), A1-A1

  BACKGROUND

• Relationship between king devick TEST, SCAR3 and 3D mot in cognitive assessment KR Oslund, HM Cullen, K Kowalski, B Christie British Journal of Sports Medicine 51 (11), A9-A10

  BACKGROUND

• Three-Dimensional Multiple Object Tracking as A Marker of Normal Cerebral Functioning after Paediatric Mild Traumatic Brain Injury: A Pilot Study LA Corbin-Berrigan, K Kowalski, J Faubert, B Christie, I Gagnon BRAIN INJURY 33, 137-138

  BACKGROUND

• 3-Dimensional Multiple Object Tracking Training Can Enhance Selective Attention, Psychomotor Speed, and Cognitive Flexibility in Healthy Older Adults CR Spaner, S Musteata, RA Kenny, JR Gawryluk, S Hofer, BR Christie Ageing Science and Mental Health Studies 3 (4), 1-12

  BACKGROUND

• A pilot study of diffusion tensor imaging metrics and cognitive performance pre and post repetitive, intentional sub-concussive heading in soccer practice RA Kenny, CD Mayo, S Kennedy, AA Varga, L Stuart-Hill, ...Journal of Concussion 3, 2059700219885503

  BACKGROUND

• Perceptual-Cognitive Training Can Improve Cognition in Older Adults with Subjective Cognitive Decline CBR Musteata Stella, Yoshida Kaya, Baranzini Daniele, Spaner Caroline ... Ageing Science and Mental Health Studies 3 (6), 1-15

  BACKGROUND

• Effects of 3D-Multiple Object Tracking on Reaction Time Performance in High-Performance Varsity Swimmers TM Snowden, KC Hogan, TJ Sparks, RG Stein, LM Melanie R, BR Christie Journal of Athletic Enhancement 9 (1), 1-12

  BACKGROUND

• Corbin-Berrigan LA, Kowalski K, Faubert J, Christie B, Gagnon I. Could Neurotracker be used as a clinical marker of recovery following pediatric mild traumatic brain injury? An exploratory study. Brain Inj. 2020 Feb 23;34(3):385-389. doi: 10.1080/02699052.2020.1723699. Epub 2020 Feb 4.

  PMID: 32013583 BACKGROUND

• Lysenko-Martin MR, Hutton CP, Sparks T, Snowden T, Christie BR. Multiple Object Tracking Scores Predict Post-Concussion Status Years after Mild Traumatic Brain Injury. J Neurotrauma. 2020 Aug 15;37(16):1777-1787. doi: 10.1089/neu.2019.6842. Epub 2020 Apr 17.

  PMID: 31950862 BACKGROUND

• Cavanagh P, Alvarez GA. Tracking multiple targets with multifocal attention. Trends Cogn Sci. 2005 Jul;9(7):349-54. doi: 10.1016/j.tics.2005.05.009.

  PMID: 15953754 BACKGROUND

• Manley G, Gardner AJ, Schneider KJ, Guskiewicz KM, Bailes J, Cantu RC, Castellani RJ, Turner M, Jordan BD, Randolph C, Dvorak J, Hayden KA, Tator CH, McCrory P, Iverson GL. A systematic review of potential long-term effects of sport-related concussion. Br J Sports Med. 2017 Jun;51(12):969-977. doi: 10.1136/bjsports-2017-097791. Epub 2017 Apr 28.

  PMID: 28455362 BACKGROUND

• Do sub-concussive impacts from soccer heading in practice cause changes in brain structure and function? (2018-09-11) Kenny, Rebecca; Christie, Brian R.; Gawryluk, Jodie R. Thesis. University of Victoria.

  BACKGROUND

• Snowden T, Ohlhauser L, Morrison J, Faubert J, Gawryluk J, Christie BR. A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. Neurotrauma Rep. 2023 Aug 14;4(1):522-532. doi: 10.1089/neur.2023.0009. eCollection 2023.

  PMID: 37645472 BACKGROUND

Related Links

• Principal Investigator website

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Jocelyn Faubert Principal Investigator, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Lugo Project Manager, PhD

CONTACT

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

Brian Christie Co-Investigator, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 17, 2025
• Study Start: March 1, 2024
• Primary Completion: July 15, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CA (3)