Brain Injuries Clinical Trial
— B-AHEAD IIOfficial title:
Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope® Ahead™ Technology
Verified date | December 2013 |
Source | BrainScope Company, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The objectives of the study are to document device performance with respect to the primary and secondary endpoints.
Status | Completed |
Enrollment | 816 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Sinai Hospital | Baltimore | Maryland |
United States | University of Maryland R Cowley Shock Trauma Center | Baltimore | Maryland |
United States | University of Virginia Medical Center | Charlottesville | Virginia |
United States | Wayne State University - Detroit Receiving Hospital | Detroit | Michigan |
United States | Wayne State University - Sinai Grace Hospital | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | INOVA Health System | Fairfax | Virginia |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Hartford Hospital | Hartford | Connecticut |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Washington University - Barnes Jewish Hospital | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
BrainScope Company, Inc. |
United States,
McCrea 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. — View Citation
Naunheim 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. — View Citation
Naunheim 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
within 24 hours of injury | No |
Secondary | 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. | within 24 hours of injury | No |
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