Brain InjuriesB-AHEAD IINCT01556711
Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
An observational study of Brain Injuries and Craniocerebral Trauma, run by BrainScope Company, Inc. at 11 sites in United States.
Trial summary
The objectives of the study are to document device performance with respect to the primary and secondary endpoints. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Injuries, Craniocerebral Trauma
- How many people
- 816 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2012to Sep 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who enter the ED at hospitals that are participating as clinical sites for this study
Who may be able to join
- Males and females ages 18 to 80 (the entire age range), who are admitted to the Emergency Department (ED), who are suspected of a traumatically induced structural brain injury and/or clinical manifestations of functional brain injury, as a result of insult to the head from an external force, e.g., the head being struck by an object, the head striking an object, the head being exposed to forces generated from a blast or explosion, and/or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head with a Glasgow Coma Scale of > 8.
- The acute, suspected traumatically induced structural brain injury and/or clinical manifestations of functional brain injury will have occurred within the past 24 hours upon admission to the ED.
- The ED normal control group will be males and females ages 18 to 80 (the entire age range), who are admitted to the ED for presenting complaints that do not involve the head or neck (no trauma above the clavicles) and no history of MVA requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope
Who cannot join
- Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.
- In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis, seizure disorder, brain tumors, history of brain surgery, mentally retarded, psychiatric disorder for which there is a prescribed psychiatric medication taken on a daily basis, substance dependence, history of TIA or stroke within the last year, currently receiving dialysis or in end-stage renal disease, active fever defined as greater than 100oF or 37.7oC, current condition is listed as "critical" in the opinion of the investigator, subject is suffering from an open head injury, subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or opioid agonist), subjects below the age of 18 years, pregnant women, and prisoners will not be eligible for study.
- ED normal control subjects will be excluded if there is a suspected neck injury or trauma above the clavicles, a primary complaint of generalized weakness, or a primary complaint of headache or migraine
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryland R Cowley Shock Trauma Center
Baltimore, Maryland, 21204
Sinai Hospital
Baltimore, Maryland, 21215
University of Virginia Medical Center
Charlottesville, Virginia, 22908-2877
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, 48201
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, 48235
Duke University Medical Center
Durham, North Carolina, 27710
INOVA Health System
Fairfax, Virginia, 22042
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
Hartford Hospital
Hartford, Connecticut, 06102-5037
University of Rochester Medical Center
Rochester, New York, 14620
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology
The objectives of the study are to document device performance with respect to the primary and secondary endpoints.
Read the detailed description
The purpose of the current study is proposed to prospectively validate the BrainScope Ahead® M-100 device design, performance, and labeling with respect to the device's target intended use and indications for use:
- Primary Endpoint:
- Structural Injury Assessment
- There are four co-primary endpoints in this study: two sets of sensitivity and specificity to divide the data into three classes.
- Using a BrainScope classification algorithm, the Ahead® M100 will identify subjects showing sensitivities among 3 classes: Green-normal, nonhead injured controls,Yellow-head injured subjects who do not exhibit brain electrical activity that is consistent with a structural brain injury observable on CT or for whom CT was not deemed necessary,Red-head injured subjects who exhibit brain electrical activity consistent with a structural brain injury observable by CT.
- Secondary Endpoint:
- Functional Injury Assessment
- There are two co-secondary endpoints for the secondary objective, the sensitivity and specificity to split Yellow from the primary endpoint into two sub groups depending on degree of brain functional impairment observable by an evaluation of the clinical findings on a clinical charter used as the assessment of truth.
- Conditions
- Brain Injuries, Craniocerebral Trauma
- Keywords
- Head Injury, Head Trauma, TBI (Traumatic Brain Injury), Emergency Department
- Medical subject headings
- Brain Injuries, Craniocerebral Trauma, Brain Injuries, Traumatic, Emergencies
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 |
|---|---|---|
| Head Injury | Males and females ages 18 to 80 (the entire age range), who are admitted to the ED, who are suspected of a traumatically induced structural brain | |
| Control | A 'normal' control group will be recruited for comparison and will consist of ED patients ("ED normal control group) who have sustained an injury but do not exhibit any trauma above the clavicle and no history of MVA requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural Brain Injury Assessment
Using a BrainScope classification algorithm, the Ahead® M-100 will identify subjects showing sensitivities among 3 classes:
Green - brain electrical activity that is consistent with patients without head injuries (Ahead® M-100 output = 1), Yellow - brain electrical activity that is consistent with head injured subjects who are abnormal, but do not have a structural brain injury (Ahead® M-100 output = 2 or 3), Red - brain electrical activity consistent with a structural brain injury observable on CT (Ahead® M-100 output = 4).
Measured: within 24 hours of injury
Secondary outcomes (1)
Functional Brain Injury Assessment
The sensitivity and specificity to split Yellow from the primary endpoint into two sub groups depending on degree of brain functional impairment observable by an evaluation of the clinical findings on the BrainScope Clinical Charter Patients classified as Yellow (b) will exhibit brain electrical activity consistent with more severe brain functional impairment. Patients classified as Yellow (a) will exhibit brain electrical activity consistent with less severe brain functional impairment observable by an evaluation of the functions on the flow chart.
Measured: within 24 hours of injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies 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
- Prospective
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainScope Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert A De Lorenzo, MD, Principal investigator, Brooke Army Medical CenterPeter Cuenca, MD, Principal investigator, Brooke Army Medical CenterSamuel M Galvagno, DO, Principal investigator, University of Maryland R. Cowley Shock Trauma CenterStephen J Huff, MD, Principal investigator, University of Virginia Medical CenterRosanne Naunheim, MD, Principal investigator, Washington University - Barnes Jewish HospitalBrian O'Neil, MD, Principal investigator, Wayne State University - Detroit Receiving HospitalBrian J O'Neil, MD, Principal investigator, Wayne State University - Sinai Grace HospitalSandeep Johar, DO, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556711
- Sponsor's protocol ID
- B-AHEAD II Trial
- Acronym
- B-AHEAD II
- Status last verified
- Dec 2013
- First submitted
- 5 Mar 2012
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Naunheim RS, Treaster M, English J, Casner T. Automated electroencephalogram identifies abnormalities in the ED. Am J Emerg Med. 2011 Oct;29(8):845-8. doi: 10.1016/j.ajem.2010.03.010. Epub 2010 May 1.
PubMed 20825903Naunheim RS, Treaster M, English J, Casner T, Chabot R. Use of brain electrical activity to quantify traumatic brain injury in the emergency department. Brain Inj. 2010;24(11):1324-9. doi: 10.3109/02699052.2010.506862.
PubMed 20722504Naunheim RS, Casner T. Novel method for detecting brain abnormality in a patient with epidural hematoma: a case report. Am J Emerg Med. 2010 Mar;28(3):386.e1-2. doi: 10.1016/j.ajem.2009.05.008.
PubMed 20223405McCrea M, Prichep L, Powell MR, Chabot R, Barr WB. Acute effects and recovery after sport-related concussion: a neurocognitive and quantitative brain electrical activity study. J Head Trauma Rehabil. 2010 Jul-Aug;25(4):283-92. doi: 10.1097/HTR.0b013e3181e67923.
PubMed 20611046
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology
- ClinicalTrials.gov ID
- NCT01556711
- Acronym / sponsor ID
- B-AHEAD II / B-AHEAD II Trial
- Conditions
- Brain Injuries, Craniocerebral Trauma
- Keywords
- Head Injury, Head Trauma, TBI (Traumatic Brain Injury), Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- BrainScope Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Mar 2012 (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 objectives of the study are to document device performance with respect to the primary and secondary endpoints.
Detailed description
The purpose of the current study is proposed to prospectively validate the BrainScope Ahead® M-100 device design, performance, and labeling with respect to the device's target intended use and indications for use:
- Primary Endpoint:
- Structural Injury Assessment
- There are four co-primary endpoints in this study: two sets of sensitivity and specificity to divide the data into three classes.
- Using a BrainScope classification algorithm, the Ahead® M100 will identify subjects showing sensitivities among 3 classes: Green-normal, nonhead injured controls,Yellow-head injured subjects who do not exhibit brain electrical activity that is consistent with a structural brain injury observable on CT or for whom CT was not deemed necessary,Red-head injured subjects who exhibit brain electrical activity consistent with a structural brain injury observable by CT.
- Secondary Endpoint:
- Functional Injury Assessment
- There are two co-secondary endpoints for the secondary objective, the sensitivity and specificity to split Yellow from the primary endpoint into two sub groups depending on degree of brain functional impairment observable by an evaluation of the clinical findings on a clinical charter used as the assessment of truth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head Injury | – | –Males and females ages 18 to 80 (the entire age range), who are admitted to the ED, who are suspected of a traumatically induced structural brain |
| Control | – | –A 'normal' control group will be recruited for comparison and will consist of ED patients ("ED normal control group) who have sustained an injury but do not exhibit any trauma above the clavicle and no history of MVA requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who enter the ED at hospitals that are participating as clinical sites for this study
Key inclusion criteria (3 listed)
- Males and females ages 18 to 80 (the entire age range), who are admitted to the Emergency Department (ED), who are suspected of a traumatically induced structural brain injury and/or clinical manifestations of functional brain injury, as a result of insult to the head from an external force, e.g., the head being struck by an object, the head striking an object, the head being exposed to forces generated from a blast or explosion, and/or the brain undergoing an acceleration/deceleration movement without direct external trauma to the head with a Glasgow Coma Scale of > 8.
- The ED normal control group will be males and females ages 18 to 80 (the entire age range), who are admitted to the ED for presenting complaints that do not involve the head or neck (no trauma above the clavicles) and no history of MVA requiring an ED visit or TBI within the past one (1) year, and no primary complaint of syncope
Key exclusion criteria (3 listed)
- Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.
- In addition, subjects with dementia, Parkinson's Disease, multiple sclerosis, seizure disorder, brain tumors, history of brain surgery, mentally retarded, psychiatric disorder for which there is a prescribed psychiatric medication taken on a daily basis, substance dependence, history of TIA or stroke within the last year, currently receiving dialysis or in end-stage renal disease, active fever defined as greater than 100oF or 37.7oC, current condition is listed as "critical" in the opinion of the investigator, subject is suffering from an open head injury, subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or opioid agonist), subjects below the age of 18 years, pregnant women, and prisoners will not be eligible for study.
- ED normal control subjects will be excluded if there is a suspected neck injury or trauma above the clavicles, a primary complaint of generalized weakness, or a primary complaint of headache or migraine
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
Structural Brain Injury Assessment
Time frame: within 24 hours of injury
Using a BrainScope classification algorithm, the Ahead® M-100 will identify subjects showing sensitivities among 3 classes: Green - brain electrical activity that is consistent with patients without head injuries (Ahead® M-100 output = 1), Yellow - brain electrical activity that is consistent with head injured subjects who are abnormal, but do not have a structural brain injury (Ahead® M-100 output = 2 or 3), Red - brain electrical activity consistent with a structural brain injury observable on CT (Ahead® M-100 output = 4).
1 secondary outcome
Functional Brain Injury Assessment
Time frame: within 24 hours of injury
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 10 Dec 2013.
- Background: PubMed 20825903Naunheim RS, Treaster M, English J, Casner T. Automated electroencephalogram identifies abnormalities in the ED. Am J Emerg Med. 2011 Oct;29(8):845-8. doi: 10.1016/j.ajem.2010.03.010. Epub 2010 May 1.
- Background: PubMed 20722504Naunheim RS, Treaster M, English J, Casner T, Chabot R. Use of brain electrical activity to quantify traumatic brain injury in the emergency department. Brain Inj. 2010;24(11):1324-9. doi: 10.3109/02699052.2010.506862.
- Background: PubMed 20223405Naunheim RS, Casner T. Novel method for detecting brain abnormality in a patient with epidural hematoma: a case report. Am J Emerg Med. 2010 Mar;28(3):386.e1-2. doi: 10.1016/j.ajem.2009.05.008.
- Background: PubMed 20611046McCrea M, Prichep L, Powell MR, Chabot R, Barr WB. Acute effects and recovery after sport-related concussion: a neurocognitive and quantitative brain electrical activity study. J Head Trauma Rehabil. 2010 Jul-Aug;25(4):283-92. doi: 10.1097/HTR.0b013e3181e67923.
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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.
Robert A De Lorenzo, MD principal investigator
Brooke Army Medical Center
Peter Cuenca, MD principal investigator
Brooke Army Medical Center
Samuel M Galvagno, DO principal investigator
University of Maryland R. Cowley Shock Trauma Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Craniocerebral Trauma, run by BrainScope Company, Inc. at 11 sites 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 3 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Structural Brain Injury Assessment (time frame: within 24 hours of injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556711, which also lists 4 linked publications.
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 10 Dec 2013.