Vascular Assessment of Regulation Index Arrays Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Neurovascular Complexity Index (NCI) measured by Varia-NCI
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Neurovascular Complexity Index (NCI) measured by Varia-NCI
Time Frame: Baseline
Patient Neurovascular Complexity Index (NCI) will be measured
Secondary Outcomes
- Cognition measured by clinical praxis(Baseline)
- Physiology measured by clinical praxis(Baseline)
- Neurovascular Complexity Index (NCI) measured by Varia-NCI(Every 4-7 days post injury; up to 6 months after injury resolution)