ConcussionVARIANCT02435082
Vascular Assessment of Regulation Index Arrays Registry
An observational study of Concussion, run by NeuroChaos Solutions, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to May 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Alcohol/substance abuse within the past 6 months, patient reported
- Serious mental illness that might preclude subject's ability to comply with treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurovascular Complexity Index (NCI) measured by Varia-NCI
Patient Neurovascular Complexity Index (NCI) will be measured
Measured: Baseline
Secondary outcomes (5)
Neurovascular Complexity Index (NCI) measured by Varia-NCI
Patient Neurovascular Complexity Index (NCI) will be measured.
Measured: Every 4-7 days post injury; up to 6 months after injury resolution
Cognition measured by clinical praxis
Patient cognitive status will be measured
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
Measured: Every 4-7 days post injury; up to 6 months after injury resolution
Cognition measured by clinical praxis
Patient cognitive status will be measured
Measured: Baseline
Physiology measured by clinical praxis
Patient physiological status will be assessed
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- NeuroChaos Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladislav Bukhman, PhD, Study chair, NeuroChaos Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435082
- Sponsor's protocol ID
- Varia-REG 1.0
- Acronym
- VARIA
- Status last verified
- May 2016
- First submitted
- 20 Apr 2015
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Assessment of Regulation Index Arrays Registry
- ClinicalTrials.gov ID
- NCT02435082
- Acronym / sponsor ID
- VARIA / Varia-REG 1.0
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NeuroChaos Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Alcohol/substance abuse within the past 6 months, patient reported
- Serious mental illness that might preclude subject's ability to comply with treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurovascular Complexity Index (NCI) measured by Varia-NCI
Time frame: Baseline
Patient Neurovascular Complexity Index (NCI) will be measured
5 secondary outcomes
Neurovascular Complexity Index (NCI) measured by Varia-NCI
Time frame: Every 4-7 days post injury; up to 6 months after injury resolution
Cognition measured by clinical praxis
Time frame: Every 4-7 days post injury; up to 6 months after injury resolution
Physiology measured by clinical praxis
Time frame: Every 4-7 days post injury; up to 6 months after injury resolution
Cognition measured by clinical praxis
Time frame: Baseline
Physiology measured by clinical praxis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Concussion
Enrolling by invitationPhase 1
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Sleep Architecture, Mild Traumatic Brain Injury
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Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladislav Bukhman, PhD study chair
NeuroChaos Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, run by NeuroChaos Solutions, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurovascular Complexity Index (NCI) measured by Varia-NCI (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.