Vascular Assessment of Regulation Index Arrays Registry

Completed

• Conditions: Concussion

• Registration Number: NCT02435082
• Lead Sponsor: NeuroChaos Solutions, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-06
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurovascular Complexity Index (NCI) measured by Varia-NCI	Baseline	Patient Neurovascular Complexity Index (NCI) will be measured

Secondary Outcome Measures

Name	Time	Method
Cognition measured by clinical praxis	Baseline	Patient cognitive status will be measured
Physiology measured by clinical praxis	Baseline	Patient physiological status will be assessed
Neurovascular Complexity Index (NCI) measured by Varia-NCI	Every 4-7 days post injury; up to 6 months after injury resolution	Patient Neurovascular Complexity Index (NCI) will be measured.

Trial Locations

Locations (1)

SportsSafe; 🇺🇸 Austin, Texas, United States