HITT Device Pilot Testing for Traumatic Brain Injury

NCT03249818 | Completed FDA Device

• 1 other identifier: rebiscan-004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (1)

• TBI monitor

  14 days

Study Arms (1)

HITT Device

OTHER

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

Interventions

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.

HITT Device

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rebiscan, Inc.: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ramon Diaz-Arrastia, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 15, 2017
• Study Start: August 22, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)