Spotting and Managing Adult Repeated Traumas in the Brain
ConditionBrain Injury Traumatic Mild
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversité de Montréal
About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Perceptual-cognitive
Other interventionThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: NeuroTrackerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
By the end of the second year.2
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.
Time frame
By the end of the second year.3
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.
Time frame
By the end of the second year.4
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).
Time frame
By the end of the second year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Université de Montréal
Lead sponsor
University of Victoria
Collaborator
NeuroTracker Athletics Inc.
Collaborator
Brain Canada
Collaborator
Consortium québécois sur la découverte du médicament
Collaborator
Source ClinicalTrials.gov