跳至主要内容
临床试验/NCT02435082
NCT02435082已完成不适用

Vascular Assessment of Regulation Index Arrays Registry

NeuroChaos Solutions, Inc.1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
Neurovascular Complexity Index (NCI) measured by Varia-NCI

研究概览

简要总结

The objective of this patient registry is to collect and analyze physiological data associated with baseline and brain injury identified in standard clinical practice (Normal Values, Recovery Curves, Correlation between Symptoms and Other Tests, NCI Index), and to assess health economics.

详细描述

The key aims of the VARIA Registry are to determine the real-life testing patterns and clinical outcomes of newly diagnosed patients with brain injury.

In accordance with the primary objective, the study will collect and analyze physiological data associated with brain injury identified in normal clinical practice with specific reference to:

  • Patient demographics, symptoms, NCI Index, and other test results,
  • Baseline ranges by demographic group,
  • Post-injury patients presenting without a baseline test to be assessed in the context of the norms for similar patients,
  • Recovery curves by demographic,
  • Health Economics.

This registry will be a prospective observational study to collect data to describe the real-life testing patterns and clinical outcomes of newly diagnosed patients with brain injury.

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
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient receiving a Transcranial Doppler for a brain injury
  • Adolescents and Adults
  • Written informed consent obtained by the clinician (may not be required for retrospective cases)

排除标准

  • Alcohol/substance abuse within the past 6 months, patient reported
  • Serious mental illness that might preclude subject's ability to comply with treatment

结局指标

主要结局

Neurovascular Complexity Index (NCI) measured by Varia-NCI

时间窗: Baseline

Patient Neurovascular Complexity Index (NCI) will be measured

次要结局

  • Cognition measured by clinical praxis(Baseline)
  • Physiology measured by clinical praxis(Baseline)
  • Neurovascular Complexity Index (NCI) measured by Varia-NCI(Every 4-7 days post injury; up to 6 months after injury resolution)

研究者

发起方
NeuroChaos Solutions, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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