Vascular Assessment of Regulation Index Arrays Registry

NCT02435082 | Completed

• 1 other identifier: Varia-REG 1.0
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Neurovascular Complexity Index (NCI) measured by Varia-NCI

  Patient Neurovascular Complexity Index (NCI) will be measured

  Baseline

Secondary Outcomes (5)

• Neurovascular Complexity Index (NCI) measured by Varia-NCI

  Every 4-7 days post injury; up to 6 months after injury resolution

• Cognition measured by clinical praxis

  Every 4-7 days post injury; up to 6 months after injury resolution

• Physiology measured by clinical praxis

  Every 4-7 days post injury; up to 6 months after injury resolution

• Cognition measured by clinical praxis

  Baseline

• Physiology measured by clinical praxis

  Baseline

Other Outcomes (1)

• Health Economic Outcomes measured by clinical praxis

  Every 4-7 days post injury; up to 6 months after injury resolution

Study Arms (1)

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).

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Alcohol/substance abuse within the past 6 months, patient reported
• Serious mental illness that might preclude subject's ability to comply with treatment

Sponsors & Collaborators

• NeuroChaos Solutions, Inc.: lead

Study Sites (1)

SportsSafe

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Vladislav Bukhman, PhD

  NeuroChaos Solutions

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 6, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)