NCT03249818

HITT Device Pilot Testing for Traumatic Brain Injury

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Rebiscan, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-22
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2017-08-15
• Last updated: 2018-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study