Establishment of Normative Data of Brain Network Activation Analysis (BNA) Using Evoked Response Potentials, in Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
研究概览
简要总结
Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in three age groups.
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
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 15-30 years.
- •Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
- •Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
排除标准
- •Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).
- •Currently with lice or open wounds on scalp.
- •Any chronic disease as determined by clinical evaluation and medical history.
- •Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
- •Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
- •History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
- •History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
- •Substance abuse in the last 3 months.
- •Significant sensory deficits, e.g., deafness or blindness.
- •History of any clinically significant brain trauma as determined by the investigator
结局指标
主要结局
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
时间窗: 1 week
The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24, 25-30 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks
次要结局
未报告次要终点