HITT Device Pilot Testing for Traumatic Brain Injury

Study Description

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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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 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
Estimated Primary Completion Date :	October 2017
Estimated Study Completion Date :	October 2017

Arms and Interventions

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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.

Outcome Measures

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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

Eligibility Criteria

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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

Contacts and Locations

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Contacts

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

Locations

United States, Pennsylvania
Penn Presbyterian Medical Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tawny Meredith-Duliba, MS 215-662-9724 Tawny.Meredith-Duliba@uphs.upenn.edu

Sponsors and Collaborators

Rebiscan, Inc.

University of Pennsylvania

Investigators

Principal Investigator:	Ramon Diaz-Arrastia, MD, PhD	University of Pennsylvania

More Information

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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Rebiscan, Inc.
ClinicalTrials.gov Identifier:	NCT03249818 History of Changes
Other Study ID Numbers:	rebiscan-004
First Posted:	August 15, 2017
Last Update Posted:	September 28, 2017
Last Verified:	September 2017
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.
URL:	http://

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