Vascular Assessment of Regulation Index Arrays Registry

Concussion Clinical Trial

— VARIA  

Official title:

Vascular Assessment of Regulation Index Arrays Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435082
• Other study ID #: Varia-REG 1.0
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: May 31, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: NeuroChaos Solutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Concussion

Locations

Country	Name	City	State
United States	SportsSafe	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NeuroChaos Solutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Economic Outcomes measured by clinical praxis	Health economic parameters and consumption of resources will be assessed.	Every 4-7 days post injury; up to 6 months after injury resolution	No
Primary	Neurovascular Complexity Index (NCI) measured by Varia-NCI	Patient Neurovascular Complexity Index (NCI) will be measured	Baseline	No
Secondary	Neurovascular Complexity Index (NCI) measured by Varia-NCI	Patient Neurovascular Complexity Index (NCI) will be measured.	Every 4-7 days post injury; up to 6 months after injury resolution	No
Secondary	Cognition measured by clinical praxis	Patient cognitive status will be measured	Every 4-7 days post injury; up to 6 months after injury resolution	No
Secondary	Physiology measured by clinical praxis	Patient physiological status will be assessed	Every 4-7 days post injury; up to 6 months after injury resolution	No
Secondary	Cognition measured by clinical praxis	Patient cognitive status will be measured	Baseline	No
Secondary	Physiology measured by clinical praxis	Patient physiological status will be assessed	Baseline	No