HITT Device Pilot Testing for Traumatic Brain Injury

NCT ID: NCT03249818

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-22
• Study Completion Date: 2018-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

HITT device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Rebiscan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramon Diaz-Arrastia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

rebiscan-004

Identifier Type: -

Identifier Source: org_study_id