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临床试验/NCT03265925
NCT03265925已完成不适用

Brain Network Activation Analysis in Epilepsy

ElMindA Ltd1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Assess the BNA database for Epilepsy population and healthy controls.

研究概览

简要总结

This is a prospective study investigating the utility of Brain Network Activation (BNA) analysis in patients with epilepsy.

详细描述

BNA technology is based on a network model to depict functional connectivity. The descriptive network model approach provides insights regarding inter-connectivity of brain networks and can describe the temporal-spatial brain activation patterns applied to various types of data-sets including EEG, MEG and fMRI.

In this study it is proposed that synchronization in brain activity may be disrupted in patients who experience frequent seizures and may correspond to functional impairments (e.g., memory, processing speed). As such, BNA analysis may provide additional data that complement current functional assessments, inform clinical assessment and management of epilepsy, and identify subgroups of patients that might be at risk for poor treatment outcomes.

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
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be between ages 18-50 years old
  • 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 consent
  • If corrected vision: only Glasses should be used during the study testing

排除标准

  • History of significant head trauma
  • Evidence of other neurologic disease
  • Any diagnosed psychiatric or systemic condition that could lead to a change in brain activity or volume (e.g., stroke, Alzheimer's disease, alcoholism).
  • Currently with lice or open wounds on scalp
  • Significant sensory deficits
  • Use of a hearing aid that occupies the ear canal
  • Substance abuse in the last 3 months and any clinically significant substance dependency
  • Additional exclusion criteria for controls are a history of any neurological disease or psychological illness.

结局指标

主要结局

Assess the BNA database for Epilepsy population and healthy controls.

时间窗: Epilepsy subjects will perform the BNA testing at baseline prior to change in medication if applicable and 3-10 days following change in medication when applicable.

Functional networks of brain activity in Epilepsy (Right and Left lobe) and healthy control individuals measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Epilepsy pathology and healthy controls.

次要结局

未报告次要终点

研究者

发起方
ElMindA Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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