Vascular Assessment of Regulation Index Arrays Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vascular Assessment of Regulation Index Arrays Registry

Conditions
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Concussion

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Concussion with TCD<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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