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Clinical Trials/NCT02435082
NCT02435082
Completed
Not Applicable

Vascular Assessment of Regulation Index Arrays Registry

NeuroChaos Solutions, Inc.1 site in 1 country13 target enrollmentApril 2015
ConditionsConcussion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Concussion
Sponsor
NeuroChaos Solutions, Inc.
Enrollment
13
Locations
1
Primary Endpoint
Neurovascular Complexity Index (NCI) measured by Varia-NCI
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
NeuroChaos Solutions, Inc.
Responsible Party
Sponsor

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

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)

Study Sites (1)

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