Clinical trial NCT02435082: Vascular Assessment of Regulation Index Arrays Registry
Official title: Vascular Assessment of Regulation Index Arrays Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: NeuroChaos Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurovascular Complexity Index (NCI) measured by Varia-NCI
timeFrame: Baseline
Secondary outcomes:
measure: Neurovascular Complexity Index (NCI) measured by Varia-NCI
timeFrame: Every 4-7 days post injury; up to 6 months after injury resolution
measure: Cognition measured by clinical praxis
timeFrame: Every 4-7 days post injury; up to 6 months after injury resolution
measure: Physiology measured by clinical praxis
timeFrame: Every 4-7 days post injury; up to 6 months after injury resolution
measure: Cognition measured by clinical praxis
timeFrame: Baseline
measure: Physiology measured by clinical praxis
timeFrame: Baseline
Other outcomes:
measure: Health Economic Outcomes measured by clinical praxis
timeFrame: Every 4-7 days post injury; up to 6 months after injury resolution
Locations:
city: Austin
country: United States
facility: SportsSafe
state: Texas
Study officials:
affiliation: NeuroChaos Solutions
name: Vladislav Bukhman, PhD
role: STUDY_CHAIR
References: