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Vascular Assessment of Regulation Index Arrays Registry (VARIA)

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ClinicalTrials.gov Identifier: NCT02435082
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
NeuroChaos Solutions, Inc.

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.

Condition or disease
Concussion

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Vascular Assessment of Regulation Index Arrays Registry
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Group/Cohort
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).



Primary Outcome Measures :
  1. Neurovascular Complexity Index (NCI) measured by Varia-NCI [ Time Frame: Baseline ]
    Patient Neurovascular Complexity Index (NCI) will be measured


Secondary Outcome Measures :
  1. Neurovascular Complexity Index (NCI) measured by Varia-NCI [ Time Frame: Every 4-7 days post injury; up to 6 months after injury resolution ]
    Patient Neurovascular Complexity Index (NCI) will be measured.

  2. Cognition measured by clinical praxis [ Time Frame: Every 4-7 days post injury; up to 6 months after injury resolution ]
    Patient cognitive status will be measured

  3. Physiology measured by clinical praxis [ Time Frame: Every 4-7 days post injury; up to 6 months after injury resolution ]
    Patient physiological status will be assessed

  4. Cognition measured by clinical praxis [ Time Frame: Baseline ]
    Patient cognitive status will be measured

  5. Physiology measured by clinical praxis [ Time Frame: Baseline ]
    Patient physiological status will be assessed


Other Outcome Measures:
  1. Health Economic Outcomes measured by clinical praxis [ Time Frame: Every 4-7 days post injury; up to 6 months after injury resolution ]
    Health economic parameters and consumption of resources will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435082


Locations
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United States, Texas
SportsSafe
Austin, Texas, United States, 78731
Sponsors and Collaborators
NeuroChaos Solutions, Inc.
Investigators
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Study Chair: Vladislav Bukhman, PhD NeuroChaos Solutions
Additional Information:

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Responsible Party: NeuroChaos Solutions, Inc.
ClinicalTrials.gov Identifier: NCT02435082    
Other Study ID Numbers: Varia-REG 1.0
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NeuroChaos Solutions, Inc.:
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