Clinical Trial Protocol for the Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents, Young Adults and Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 964
- 试验地点
- 5
- 主要终点
- Developing a BNA database for normative population.
研究概览
简要总结
Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked response potentials in adolescents, young adults and Adults.
Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to 1500 subjects will be enrolled in 4 or more sites. Study duration: Each patient will be followed up for up to 1 year. Overall study duration will be up to 1.5 years. Patient population: Adolescents, young adults and Adults of both genders.
Age range:
- 10-11.99
- 12-13.99
- 14-15.99
- 16-17.99
- 18-24.99
- 25-29.99
- 30-34.99
- 35-39.99
- 40-44.99
- 45-49.99
- 50-54.99
- 55-60
- 60 and above
Objective: Establishment of normative data of BNA.
详细描述
Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a non-invasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.
The need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Developing a BNA database for normative population.
时间窗: 1.5 years
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
次要结局
未报告次要终点
