Vascular Assessment of Regulation Index Arrays Registry (VARIA)

NeuroChaos Solutions

Status: Completed

Conditions: Concussion

Study type: Observational

Funder types: Industry

Identifiers

NCT02435082

Varia-REG 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

13 participants in 1 patient group

Concussion with TCD

Description:

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).