Back to resultsHITT Device Pilot Testing for Traumatic Brain Injury
Primary Purpose
Brain Injuries, Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HITT device
Sponsored by
About this trial
This is an interventional device feasibility trial for Brain Injuries, Traumatic
Eligibility Criteria
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
Sites / Locations
- Penn Presbyterian Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HITT Device
Arm Description
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
Outcomes
Primary Outcome Measures
TBI detection
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
TBI monitor
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
Full Information
NCT ID
NCT03249818
First Posted
August 9, 2017
Last Updated
August 28, 2018
Sponsor
Rebiscan, Inc.
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03249818
Brief Title
HITT Device Pilot Testing for Traumatic Brain Injury
Official Title
Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rebiscan, Inc.
Collaborators
University of Pennsylvania
4. Oversight
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HITT Device
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
HITT device
Intervention Description
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 Measure Information:
Title
TBI detection
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
TBI monitor
Description
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
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Diaz-Arrastia, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
HITT Device Pilot Testing for Traumatic Brain Injury
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