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HITT Device Pilot Testing for Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03249818
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Rebiscan, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Device: HITT device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
Actual Study Start Date : August 22, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
HITT Device
HITT device to scan eyes of participants 3 times (30 seconds each) at time of admittance to hospital for diagnosed traumatic brain injury. If patient is still in hospital 2 weeks post-enrollment, a second set of 3 tests will be performed
Device: HITT 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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Catastrophic polytrauma that would interfere with follow-up and outcome assessment
  2. Prisoners or patients in custody
  3. Pregnancy in female subjects
  4. Patients on psychiatric hold (e.g. 5150, 5250)
  5. Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessment
  6. Major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
  7. 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)
  8. Low likelihood of follow-up (e.g. participant or family indicating low interest, homelessness or lack of reliable contacts)
  9. Penetrating TBI
  10. Spinal cord injury with ASIA (American Spinal Injury Assoc.) score of C or worse
  11. 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.
  12. History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
  13. Intoxication or chemical impairment at time of examination (upon initial presentation)
  14. Evidence on hand-light examination of obvious ocular anomaly or misalignment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249818


Locations
United States, Pennsylvania
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Rebiscan, Inc.
University of Pennsylvania
Investigators
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD University of Pennsylvania

Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT03249818     History of Changes
Other Study ID Numbers: rebiscan-004
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Aggregate data and individual test reports will be made available to the HITT device manufacturer to better understand its performance at identifying TBI. Personal identifiable data will not be shared with anyone outside of the University of Pennsylvania.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Data will be shared on an ongoing basis, and cumulatively at the end of the study. Study length is expected to be 2 months from first enrolled participant.
Access Criteria: Data will only be shared with researchers involved in the study at the University of Pennsylvania, and only trained staff members at the device manufacturer.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries