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Completed

NCT Number: NCT03249818

HITT Device Pilot Testing for Traumatic Brain Injury

The purpose of this research study is to collect data from the eyes of traumatic brain injury (TBI) patients. Patients will look at a green target that will measure the fixation of the eye for 30 seconds. In that 30 seconds, the location of the green target will change and the participant is to track, with their eyes, the light as best they can. The device will measure how well fixation was maintained and the speed of the saccadic movements of the eye. Data will then be used to determine whether there is correlation between these measures and known TBI.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18-40
  • Documented/ verified mild TBI
  • Mild traumatic brain injury will be defined as Glasgow Coma Scale (GCS) of ≥13 at time of study enrollment
  • Injury occurred < 24 hours ago
  • Positive acute brain CT for clinical care
  • Visual acuity/ hearing adequate for testing
  • Fluency in English or Spanish
  • Ability to provide informed consent
  • Enrolled in TRACK-TBI (IRB #: 825503)

Exclusion criteria

  • Catastrophic polytrauma that would interfere with follow-up and outcome assessment
  • Prisoners or patients in custody
  • Pregnancy in female subjects
  • Patients on psychiatric hold (e.g. 5150, 5250)
  • Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessment
  • Major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
  • Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g. substance abuse, alcoholism, HIV/AIDS, major transmittable diseases that may interfere with consent, end-stage cancers, learning disabilities, developmental disorders)
  • Low likelihood of follow-up (e.g. participant or family indicating low interest, homelessness or lack of reliable contacts)
  • Penetrating TBI
  • Spinal cord injury with ASIA (American Spinal Injury Assoc.) score of C or worse
  • Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
  • History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
  • Intoxication or chemical impairment at time of examination (upon initial presentation)
  • Evidence on hand-light examination of obvious ocular anomaly or misalignment

Treatment and study plan

HITT device

Device

Device scans the fovea of the eye to measure fixation. Patients will then be asked to track the fixation target across an area the size of a playing card, with the device tracking the participant's fixation throughout.

Primary outcomes

  1. TBI detection

    Time frame: 1 day

    Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI

Secondary outcomes

  1. TBI monitor

    Time frame: 14 days

    Patients who have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI

Sponsors and collaborators

Lead sponsor

Rebiscan, Inc.

Industry

Collaborators

  • University of Pennsylvania

Registry information

Official study title

Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2017
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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