Offsetting Hippocampal Degeneration in Moderate to Severe TBI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion
研究概览
简要总结
The goal of this study is to establish the feasibility of an intervention designed to improve memory in patients who have experienced a moderate or severe traumatic brain injury (m-sTBI) and to examine its effect on brain structures.
详细描述
The purpose of this study is to establish the feasibility of a novel intervention, and explore biomarker predictors of neurodegeneration and response to the proposed intervention. This 16 week intervention utilises allocentric spatial navigation tasks to improve memory and counteract hippocampal neurodegeneration. This intervention will be administered in combination with neuropsychological assessments, MR imaging, and the analysis of genomic variants at two time points; 7 months post-TBI and 12 months post-TBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The psychometrist will be blind to the arm the participant is assigned to.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An acute care diagnosis of TBI as determined by a medical professional, indicated by:
- •Post-traumatic amnesia duration of 24 hours or more, and/or lowest Glasgow Coma Scale score of < 13
- •Positive clinical CT or MRI scan
- •Aged 18 to 65
- •Fluent in English
- •Have the competency for fully informed consent by 6 months post-injury
- •Have basic computer skills
- •Have functional use of one upper extremity
- •Have access to the internet
排除标准
- •A neurological disorder other than TBI (e.g., stroke, dementia, tumor, neurodevelopmental disorder) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.
- •A systemic condition (e.g., lupus, diabetes, rheumatoid arthritis).
- •Any contraindications to magnetic resonance imaging (MRI)
- •You are experiencing language impairments (i.e., aphasia) from your injury
结局指标
主要结局
Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion
时间窗: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
Measurement of pattern completion abilities are assessed in a task designed to probe pattern completion by presenting partial retrieval cues at different levels of degradation. The following variables are taken into account: i) accuracy for learned stimuli given as a percentage value (i.e., correctly selecting the name of the scene) ii) accuracy for new stimuli given as a percentage value (i.e., correctly indicating the stimuli is novel) and iii) bias measure. The bias measure is obtained by subtracting the learned stimuli accuracy score from the new stimuli accuracy score. An increase for both accuracy measures from pre- to post-intervention corresponds to improvement on recognition memory. An increase in bias measure reflects an increased tendency for pattern separation.
Online Spatial Navigation Intervention Test Scores: Change in Spatial Learning Ability
时间窗: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
Participants complete online spatial navigation training 5 days per week for 16 weeks. Improvement in spatial learning ability will be assessed based on the accuracy of answers to questions regarding the reproduction of spatial elements, the direction and proximity of certain landmarks, and describing the most efficient route from point A to point B. Improvement will be assessed at the end of each week and at the end of the intervention. The raw scores range from 0-15, with higher scores indicating better spatial learning ability.
Online Spatial Navigation Intervention Test Scores: Change in Pattern Separation
时间窗: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
Measurement of pattern separation abilities are assessed in a task requiring the participant to differentiate memories in order to prevent interference from overlapping details. The following three variables are taken into account: i) percent correct ii) the discriminating value and iii) bias metric. Percent correct and bias metric are given as a percentage values (e.g., 80.63%) and the discriminating variable is given as a raw rate (e.g., 0.67). An improvement in pattern separation abilities are determined by an increase in percent correct and discrimination values from pre- to post-intervention. An increase in bias metric from pre- to post-intervention reflects an increased tendency for pattern separation.
Online Spatial Navigation Intervention Test Scores: Change in Cognitive Map Formation
时间窗: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
Participants complete online spatial navigation training 5 days per week for 16 weeks. Improvement in cognitive map formation will be assessed based on the number of trails required by the participant to learn landmark placements and based on the accuracy of the participant's navigation to a specific destination. The raw scores range from 1-21 and 0-10, respectively. A decrease in the number of trials required by the participant and an increase in navigation accuracy both correspond to an improvement in cognitive map formation.
次要结局
- Neuronal injury biomarker predictors in serum and plasma samples(Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury)
- Gliosis and inflammation biomarker predictors in serum samples(Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury)
研究者
William Panenka
Principal Investigator
University of British Columbia