Neurophysiological Measurements in the Pediatric Concussion Population: An Initial Assessment Using the NeuroCatch™ Platform
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Tracking and comparison of neurophysiological changes (ERP response size) to persistence of mTBI symptoms
研究概览
简要总结
EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. The current research is primarily focused on three ERP components: the N100, P300 and N400. Each of the three ERPs have been studied in the academic laboratory for multiple decades. Through this research, a strong understanding has been developed regarding what can affect these components (e.g. task set, emotional state, etc.). However, these signals within various pediatric populations (e.g., those with persistent mTBI symptoms or multiple concussions) are not well characterized.
Being able to safely and effectively employ the NeuroCatch™ Platform in a post-concussive pediatric cohort could provide researchers with the potential to elucidate the persistence of objective measures of impairment, patterns of recovery, and chronicity of problems due to mTBI in children. Secondly, understanding the degree to which these neurophysiological components fluctuate over time is crucial to the understanding of brain functioning. However, for this type of technology to be useful in quantifying brain health in this population,the degree to which a post-concussive pediatric brain naturally fluctuates in its processing capability must be quantified. NeuroCatch™ Platform has the ability to measure changes in several domains of brain function. These cognitive processes are foundational blocks for some of the highest cognitive processes: information integration and executive functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male, female, or intersex
- •8-18 years old inclusively
- •Must meet all criteria in one of the following cohorts:
- •Cohort 1: Has persistent mTBI symptoms 6-16 weeks post-injury, as determined by the Investigator;
- •Cohort 2: Recovered quickly (within approximately six weeks) from mTBI, as determined by the Investigator 6-16 weeks post-injury;
- •Cohort 3: Has had multiple mTBIs (2 or more medically verified concussions over the last year) with the most recent injury having occurred 6-16 weeks prior to study enrollment;
- •Cohort 4: Has never had a concussion.
排除标准
- •Previous neurological illnesses (e.g., epilepsy or seizure disorders) including moderate to severe learning difficulties, as determined by the Investigator
- •Clinically documented hearing issues (e.g., tinnitus, in-ear hearing problems, punctured ear drum)
- •In-ear hearing aid or cochlear implant, hearing devices
- •Implanted pacemaker
- •Metal or plastic implants in skull
- •Allergy to rubbing alcohol or EEG gel
- •Previous participation in one or more studies using the NeuroCatchTM Platform
- •Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
- •Using other investigational drugs or devices while enrolled in this study
- •Not fluent in the English language
- •If female and of child-bearing potential: suspected or planning to become pregnant, currently pregnant, or breast-feeding
结局指标
主要结局
Tracking and comparison of neurophysiological changes (ERP response size) to persistence of mTBI symptoms
时间窗: 1 day
Response size will be measured as amplitude in microvolts. Persistence of mTBI symptoms will be defined by cohort.
Tracking and comparison of neurophysiological changes (ERP response timing) to persistence of mTBI symptoms
时间窗: 1 day
Response timing will be measured as latency in milliseconds. Persistence of mTBI symptoms will be defined by cohort.
次要结局
- Number of adverse events and adverse device effects(1 day)
- Collection of ERP response size (amplitude in microvolts) and response timing (latency in milliseconds)(1 day)
研究者
Dr. Michael Esser
Principal Investigator
Alberta Children's Hospital