Status:
COMPLETED
Pilot Study of NeuroTriage Device in Patients with Potential Brain Injury And/or Impairment
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-89 years
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 ...
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, an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03761641
Start Date
March 1 2015
End Date
November 15 2015
Last Update
October 15 2024
Active Locations (1)
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1
Parkland Memorial Hospital
Dallas, Texas, United States, 75235