Pilot Study of NeuroTriage Device in Patients With Potential Brain Injury and/or Impairment

Study personnel will identify potential subjects in the ED, hospital and ICU during "peak
hours" as appropriate through conferring with medical records, trauma logs, triage notes, and
head CT, MRI, and other brain imaging orders as well as on-duty doctors and nurses to
identify potential subjects. Many of the inclusion/exclusion criteria can be evaluated by a
review of the potential subject's medical records, such as mechanism of injury or impairment,
extent of non-head injuries, prior medical history, and prior clinical visits at the center
of care. When a potential subject is identified and has been screened against the primary set
of inclusion/exclusion criteria, they will be approached about the study.

Prior to enrolling a subject, the research personnel will screen the subject for competency
to provide informed consent. This is necessary because, by its very nature, suspected brain
injury patients may or may not be able to initially provide informed consent. The Galveston
Orientation and Amnesia Test (GOAT) will be used as the standard assessment instrument for
this screening. A score of 75 or greater on the GOAT would indicate that the subject is
competent to provide informed consent. If the subject scores < 75 on the GOAT, then consent
must be provided by a Legally Authorized Representative (LAR). This is a threshold of
competency that has been used in previous studies here at UTSW.

Potential subjects that pass the GOAT will be given time to read the Consent Form and to
consult with family members who may be present or by phone. If the subject agrees to
participate, then they will sign the appropriate forms. A copy of the form will be given to
the subject. The NeuroTriage and GOAT will then be serially performed on the patient no more
than once every two hours (particularly in the ED, where the stay is often short) or with
changes in neurological status.

Criteria for Inclusion of Subjects:

One hundred individuals presenting to Parkland Emergency Department, Zale Lipshy and
Clements Hospital for treatment diagnosed to be any form of mild, moderate or severe TBI,
between the ages of 18 and 65 will be given the opportunity to participate in this study.

Patients injury should have occurred within the past 24 hours,and have an acute brain CT
performed based on clinical care. We will enroll patients presenting to the Emergency
Department (ED) with a history of TBI as per American Congress of Rehabilitation
Medicine(ACRM) Criteria, in which the patient has sustained a traumatically induced*
physiological disruption of brain function, as manifested by ≥ one of the following:

- Any period of loss of consciousness (LOC)

- Any loss of memory for events (e.g. amnesia) immediately before or after the accident-

- Any alteration of mental state at the time of the accident (feeling dazed,
disoriented, and/or confused)

- Focal neurologic deficits that may or may not be permanent

Traumatically induced includes the head being struck, the head striking an object, or the
brain undergoing an acceleration/deceleration movement (e.g. whiplash) without direct
external trauma to the head.

All patients will need to be fluent in English or Spanish and be able to personally provide
informed consent or have a legally authorized representative provide informed consent.

Individuals will not be excluded based on gender or race.

Criteria for Exclusion of Subjects:

Patients who have a penetrating Traumatic Brain Injury or a Spinal Cord Injury with ASIA
score of C or worse will not be eligible for enrollment in this study.

- Any patients that are already participating in an interventional trial (e.g. drug,
devise or behavioral) will be excluded.

- Non-English or Spanish speakers will be excluded.

- Any cognitive defect that limits comprehension of the study procedures and risks
associated will be excluded.

- Patients with significant polytrauma that would interfere with assessments.

- Patients that have a significant history of pre-existing conditions that would
interfere assessments (e.g.substance abuse, alcoholism, HIV/AIDS, major transmittable
diseases that may interfere with consent, endstage cancers, learning disabilities, and
developmental disorders).

- Patients on psychiatric hold or patients with a major debilitating mental health
disorder (e.g. schizophrenia or bipolar disorder) will be excluded as they may
interfere with follow-up and the validity of assessments.

- Patients with major debilitating neurological disease (e.g. stroke, CVA, dementia,
tumor) impairing baseline awareness,cognition, or validity of follow-up and outcome
assessment.

- Pregnancy in female subjects and prisoners in custody will be excluded.