HITT Device Pilot Testing for Traumatic Brain Injury

Brain Injuries, Traumatic Clinical Trial

Official title:

Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249818
• Other study ID #: rebiscan-004
• Status: Completed
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2018
• Source: Rebiscan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	14 days