Vascular Assessment of Regulation Index Arrays Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02435082

Acronym

VARIA

Enrollment

Registered

2015-05-06

Start date

2015-04-30

Completion date

2016-05-31

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion

Keywords

Concussion, Vascular Assessment, Vascular Regulation, mild Traumatic Brain Injury, mTBI, Traumatic Brain Injury, TBI, Cerebrovascular Regulation, Cerebral Blood Flow, Cerebral Blood Flow Velocity, CBFV, Cerebral Blood Flow Velocity Variability, Cerebrovascular Assessment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Neurovascular Complexity Index (NCI) measured by Varia-NCI	Baseline	Patient Neurovascular Complexity Index (NCI) will be measured

Secondary

Measure	Time frame	Description
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.
Cognition measured by clinical praxis	Every 4-7 days post injury; up to 6 months after injury resolution	Patient cognitive status will be measured
Physiology measured by clinical praxis	Every 4-7 days post injury; up to 6 months after injury resolution	Patient physiological status will be assessed

Other

Measure	Time frame	Description
Health Economic Outcomes measured by clinical praxis	Every 4-7 days post injury; up to 6 months after injury resolution	Health economic parameters and consumption of resources will be assessed.

Countries

United States

Outcome results