Clinical trial NCT03761641: Pilot Study of NeuroTriage Device in Patients with Potential Brain Injury And/or Impairment
Official title: Pilot Study of NeuroTriage Device in Patients with Potential Brain Injury And/or Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to Parkland ED with suspected brain injury greater than 18 years of age, of an race or gender. Patients will need to be fluent in Spanish or English

Brief summary: This protocol is aimed at collecting oculomotor response data from a variety of brain injuries and impairments, and to secondarily evaluate the functionality and ease of use of the NeuroTriage device in the ED in patients with any presumed brain injury and/or impairment. For example, prior studies in adolescents with a concussion have shown that they tend to overshoot the pattern when asked to follow the movement of the lights in the binoculars

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Calibration of Neurotriage Device
timeFrame: Through study completion, 1 year
measure: Enjoyment of Neurotriage Device Use
timeFrame: Through Study Completion, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Jane G Wigginton, MD
role: PRINCIPAL_INVESTIGATOR
References: