Developing an Evidence-based Approach to Diagnose and Treat Adults With a History of Concussion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Neuropsychological cognitive assessments
研究概览
简要总结
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.
详细描述
Older adults with a history of concussions have a 2x greater risk of developing dementia, however it is not clear why some individuals show resilience and are cognitively healthy, while others struggle and show more pronounced cognitive deficits. Concussions are a form of mild traumatic brain injury (mTBI) that are induced by the impact of biomechanical forces on the brain. In Canada, there are approximately 94,000 activity-limiting concussions per year in individuals aged 12 and over (Statistics Canada). Despite increasing awareness of concussion risks, the objective assessment of long-term consequences of concussion remains a notoriously difficult clinical problem; a multimodal approach is required to improve the understanding and treatment of individuals with a history of mTBI.
Advancement of Technology: NeuroTracker is a state-of-the-art technology which shows promise as a functional biomarker of brain-health, as well as cognitive training tool. NeuroTracker has the ability to serve as an accessible detection method and therapeutic for adults at risk of dementia due to a history of concussion.
Objectives & Experimental Approach: The goal of this research project will be to examine aging older adult males and females with a history of concussion to determine if there are biomarkers that are indicative of cognitive trajectories.
Aim 1 will investigate cognitive-differences in individuals with a history of concussion. The investigators will examine the results of comprehensive neuropsychological and NeuroTracker assessments and task-based neurocognitive performance in older adults (60+ years) with and without histories of concussion.
Aim 2 will identify unique biomarkers from individuals with a history of concussion. The investigators will examine neuroimaging metrics, biomarkers obtained from blood samples, and NeuroTracker performance metrics from older males and females with and without a history of concussion. These results will be compared with those from Aim 1 to help identify positive and negative prognostic predictors for cognitive performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Neuropsychological cognitive assessments
时间窗: By the end of the second year.
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).
Multimodal biomarker assessment
时间窗: By the end of the second year
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).
NeutroTracker assessement
时间窗: By the end of the second year
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.
次要结局
未报告次要终点
研究者
Eduardo Lugo Arce
Coordinator
Université de Montréal