Vascular Assessment of Regulation Index Arrays Registry (VARIA)

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.

Study Overview

• Status: Completed
• Conditions: Concussion

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78731
      • SportsSafe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients contacting a clinic to schedule an appointment for evaluation of the brain (pre or post injury) will be informed about the registry and will be given the option to participate.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Concussion with TCD; Any patient (adolescent/adult) receiving a Transcranial Doppler (TCD) for a head injury, suspected concussion, or suspected mild traumatic brain injury (sports related or not).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NeuroChaos Solutions, Inc.
• Investigators: Study Chair: Vladislav Bukhman, PhD, NeuroChaos Solutions

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Concussion; Cerebral Blood Flow; Vascular Assessment; Vascular Regulation; mild Traumatic Brain Injury, mTBI; Traumatic Brain Injury, TBI; Cerebrovascular Regulation; Cerebral Blood Flow Velocity, CBFV; Cerebral Blood Flow Velocity Variability; Cerebrovascular Assessment
• Other Study ID Numbers: Varia-REG 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No