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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Neurovascular Complexity Index (NCI) measured by Varia-NCI | Patient Neurovascular Complexity Index (NCI) will be measured | Baseline |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Vladislav Bukhman, PhD | NeuroChaos Solutions | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SportsSafe | Austin | Texas | 78731 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |