Traumatic Brain InjuryTBINCT02471625
Traumatic Brain Injury Feasibility Study (EPIC-011)
An observational study of Traumatic Brain Injury and Controls, run by Epic Research & Diagnostics, Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Controls
- What is being tested?
- ClearView Scanning
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to May 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women ages 18-65 who present to the ER with suspected head trauma and meet all inclusion and no exclusion criteria will be approached for consent to participate in the study.
Who may be able to join
- Suspected TBI population:
- Acute head trauma within 24-72 hours of presentation
- 18-65 age inclusive
- GCS of 3-15 on initial evaluation in ED
- Control population:
- 18-65 age inclusive
- GCS score of 15
Who cannot join
- Current neurological disease
- Current severe psychological disorder
- History of substance or alcohol abuse
- Under drug or alcohol influence, if so, must wait at least 24 hrs. prior to consent
- Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
- Current treatment to the head/brain (radiation, whole brain therapy, gamma knife)
Show all 16Show fewer
- Head injury in the last two years
- Unwilling to sign informed consent
- Pregnant or potentially pregnant
- Pacemaker, automatic implanted cardiac defibrillator or other implanted electrical device
- Connected to an electronic device that cannot be removed
- Missing all or part of fingers or cuts/burns on pads of fingers
- Long fingernails and unwilling to cut them and keep them cut for the duration of the study
- Hand tremors or involuntary oscillations ("shaking") of the hands that prevents clear imaging
- Additional exclusion criteria for control population:
- Previous head trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™
The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.
Read the detailed description
Traumatic brain injury (TBI) is a significant cause of death and disability in the U.S. The severity of a TBI may range from "mild" (i.e. a brief change in mental status or consciousness) to "severe" (i.e. an extended period of unconsciousness or memory loss after the injury). However, most TBI's that occur each year are mild and are commonly called concussions. Unfortunately, TBI terminology does not adequately describe the injury or impairment, its treatment, or the resulting outcomes. Due to the complexity of the human brain, each person's physiology can result in different patterns of impairment and secondary conditions, requiring different treatment or rehabilitation. The intent of EPIC ClearView™ TBI Feasibility (EPIC-011) is to collect data to further develop the ClearView™ Response Scale to measure electrophysiology associated with TBI
- Conditions
- Traumatic Brain Injury, Controls
- Being tested
- ClearView Scanning
- Keywords
- Controls
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearView ScanningDevice
| Study group | Role | What they receive |
|---|---|---|
| Traumatic Brain Injury | Men and women ages 18-65 with suspected acute head trauma within 24-72hrs. of presentation, scoring a 3-15 on initial evaluation on GCS scale. | |
| Control | Men and women ages 18-65 with no history of head trauma and a score of 15 on the GCS scale. Receives: Device: ClearView Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of ClearView Scan versus Active Diagnosis
The EPIC ClearView software produces a Response Scale report that summaries the electrophysiological measurements associated with organ systems. The autonomic numbers indicate how the person's stress response is affecting different body systems and the physical numbers reflect physiological function. These measurements will then be compared to TBI diagnosis, based on one or two possible scans
Measured: I day unless TBI population chooses to participate in one week follow up
Secondary outcomes (1)
Comparison of TBI subjects to Controls
Will measure comparisons of data from one visit
Measured: 1 day unless TBI population chooses to participate in one week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epic Research & Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471625
- Sponsor's protocol ID
- EPIC-011
- Acronym
- TBI
- Status last verified
- Nov 2015
- First submitted
- 4 Jun 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™
- ClinicalTrials.gov ID
- NCT02471625
- Acronym / sponsor ID
- TBI / EPIC-011
- Conditions
- Traumatic Brain Injury, Controls
- Keywords
- Controls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Epic Research & Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 15 Jun 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 purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.
Detailed description
Traumatic brain injury (TBI) is a significant cause of death and disability in the U.S. The severity of a TBI may range from "mild" (i.e. a brief change in mental status or consciousness) to "severe" (i.e. an extended period of unconsciousness or memory loss after the injury). However, most TBI's that occur each year are mild and are commonly called concussions. Unfortunately, TBI terminology does not adequately describe the injury or impairment, its treatment, or the resulting outcomes. Due to the complexity of the human brain, each person's physiology can result in different patterns of impairment and secondary conditions, requiring different treatment or rehabilitation. The intent of EPIC ClearView™ TBI Feasibility (EPIC-011) is to collect data to further develop the ClearView™ Response Scale to measure electrophysiology associated with TBI
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury | – | –Men and women ages 18-65 with suspected acute head trauma within 24-72hrs. of presentation, scoring a 3-15 on initial evaluation on GCS scale. |
| Control | – | Device: ClearView ScanningMen and women ages 18-65 with no history of head trauma and a score of 15 on the GCS scale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women ages 18-65 who present to the ER with suspected head trauma and meet all inclusion and no exclusion criteria will be approached for consent to participate in the study.
Key inclusion criteria (7 listed)
- Acute head trauma within 24-72 hours of presentation
- 18-65 age inclusive
- GCS of 3-15 on initial evaluation in ED
- 18-65 age inclusive
- GCS score of 15
Key exclusion criteria (16 listed)
- Current neurological disease
- Current severe psychological disorder
- History of substance or alcohol abuse
- Under drug or alcohol influence, if so, must wait at least 24 hrs. prior to consent
- Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearView Scanning | Device | Control |
Primary outcome
Agreement of ClearView Scan versus Active Diagnosis
Time frame: I day unless TBI population chooses to participate in one week follow up
The EPIC ClearView software produces a Response Scale report that summaries the electrophysiological measurements associated with organ systems. The autonomic numbers indicate how the person's stress response is affecting different body systems and the physical numbers reflect physiological function. These measurements will then be compared to TBI diagnosis, based on one or two possible scans
1 secondary outcome
Comparison of TBI subjects to Controls
Time frame: 1 day unless TBI population chooses to participate in one week follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Traumatic Brain Injury and Controls, run by Epic Research & Diagnostics, 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 20 Nov 2015. 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?
Results are not available in the source record.
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?
Agreement of ClearView Scan versus Active Diagnosis (time frame: I day unless TBI population chooses to participate in one week follow up). 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 20 Nov 2015.