NCT07025317 Spotting and Managing Adult Repeated Traumas in the Brain
| NCT ID | NCT07025317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université de Montréal |
| Condition | Brain Injury Traumatic Mild |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-03-01 with a primary completion date of 2025-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Jocelyn Faubert Principal Investigator, PhD
PRINCIPAL INVESTIGATOR
Université de Montréal
Frequently Asked Questions
Who can join the NCT07025317 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Brain Injury Traumatic Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07025317 currently recruiting?
Yes, NCT07025317 is actively recruiting participants. Contact the research team at eduardo.lugo.arce@umontreal.ca for enrollment information.
Where is the NCT07025317 trial being conducted?
This trial is being conducted at Victoria, Canada, Victoria, Canada, Montreal, Canada.
Who is sponsoring the NCT07025317 clinical trial?
NCT07025317 is sponsored by Université de Montréal. The principal investigator is Jocelyn Faubert Principal Investigator, PhD at Université de Montréal. The trial plans to enroll 200 participants.