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HITT Device Pilot Testing for Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03249818
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

August 9, 2017
August 15, 2017
September 28, 2017
August 22, 2017
October 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03249818 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
HITT Device Pilot Testing for Traumatic Brain Injury
Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Brain Injuries, Traumatic
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.
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
Intervention: Device: HITT device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
October 2017
October 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
No
Contact: Ramon Diaz-Arrastia, MD, PhD 215-662-9732 Ramon.Diaz-Arrastia@uphs.upenn.edu
Contact: Justin Shaka, MBA 857-600-0982 jgshaka@rebion.net
United States
 
 
NCT03249818
rebiscan-004
No
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
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
Supporting Materials: 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.
URL: http://
Rebiscan, Inc.
Rebiscan, Inc.
University of Pennsylvania
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD University of Pennsylvania
Rebiscan, Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP