Pilot Study of NeuroTriage Device in Patients with Potential Brain Injury And/or Impairment

NCT03761641 | Completed

• 1 other identifier: 012015-030
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Calibration of Neurotriage Device

  Evaluate the number of rehabilitation device failure as reported by study team

  Through study completion, 1 year

• Enjoyment of Neurotriage Device Use

  Assess feasibility, ease of use and enjoyment for device in injured population. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware, changes will be made based on feedback received from participants.

  Through Study Completion, 1 year

Interventions

Neurotriage OTHER

NeuroTriage binocular handset monitors pupil dynamics \& eye position with infrared cameras. Rubber non-allergenic ocular spacers contoured to eye sockets come in contact with the face \&cushion between the skin \& eyepiece. During pupil dilation tests, an LED briefly illuminates the pupil. The NeuroTriage system measures neurological pupil index, constriction velocity, \& dilation velocity. Total pupil dilation testing time is \< 1 minute. During saccade-tracking tests, patients direct their gaze towards dim LED targets selectable across the range of view. Visual targets involve center-out ocular motion or smooth pursuit following of illusory movement. The NeuroTriage system measures eye position \& movement velocity during these tests. Total saccade-tracking testing takes \< 3 minutes. Ocular measures are non-invasive, are done quickly and commonly used to measure neurological function.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jane G Wigginton, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: December 3, 2018
• Study Start: March 1, 2015
• Primary Completion: November 15, 2015
• Study Completion: November 15, 2015
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)