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OpenTrials
Completed

NCT Number: NCT02435082

Vascular Assessment of Regulation Index Arrays Registry

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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SportsSafe

Austin, Texas, 78731, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Neurovascular Complexity Index (NCI) measured by Varia-NCI

    Time frame: Baseline

    Patient Neurovascular Complexity Index (NCI) will be measured

Secondary outcomes

  1. Neurovascular Complexity Index (NCI) measured by Varia-NCI

    Time frame: Every 4-7 days post injury; up to 6 months after injury resolution

    Patient Neurovascular Complexity Index (NCI) will be measured.

  2. Cognition measured by clinical praxis

    Time frame: Every 4-7 days post injury; up to 6 months after injury resolution

    Patient cognitive status will be measured

  3. Physiology measured by clinical praxis

    Time frame: Every 4-7 days post injury; up to 6 months after injury resolution

    Patient physiological status will be assessed

  4. Cognition measured by clinical praxis

    Time frame: Baseline

    Patient cognitive status will be measured

  5. Physiology measured by clinical praxis

    Time frame: Baseline

    Patient physiological status will be assessed

Other outcomes

  1. Health Economic Outcomes measured by clinical praxis

    Time frame: Every 4-7 days post injury; up to 6 months after injury resolution

    Health economic parameters and consumption of resources will be assessed.

Sponsors and collaborators

Lead sponsor

NeuroChaos Solutions, Inc.

Industry

Registry information

Acronym: VARIA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2015
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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