Health TrialsbyHealthPanel

mTBI Identification and Monitoring Through Retinal Scanning

ConditionBrain Injuries, Traumatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorRebiscan, Inc.

About this trial

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-45 years

Presents to the facility within 2 weeks of head trauma

Able to provide informed consent

If minor, then able to provide parental consent and minor consent

Disqualifiers

Glasgow Coma Scale score equal to or less than 13 at the time of study enrollment

Under the influence of alcohol or drugs

Previous eye surgery

Visual acuity known to be 20/200 or less in either eye

Trial population

The population includes target participants that enroll within two weeks of blunt head trauma, with a Glasgow Coma Scale score equal to or greater than thirteen, A minimum of sixty Target Condition subjects will be enrolled. All studies will be complete within thirty days of enrollment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Head and Intraocular Trauma Tool

    Device

    HITT device to scan the eyes of participants up to 3 times (\~45 seconds each) at the time of admittance to study. The participant is to place the chin in the chin-rest and fixate on the illuminated light on the device.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Controls1 intervention
Group B: TBI-Suspected Patients1 intervention

Trial outcomes

Primary outcomes

1

TBI Detection

Patients who present with suspected TBI to the clinic will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI.

Time frame
1 day

Secondary outcomes

1

TBI Monitor

Patients who present with suspected TBI to the clinic and had initially been tested for TBI detection will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI.

Time frame
14 days
2

TBI Monitor

Patients who present with suspected TBI to the clinic and had initially been tested for TBI detection will receive a second set fo scans at one month to identify whether the HITT device can accurately identify patients with TBI.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rebiscan, Inc.

Lead sponsor

Boston Medical Center

Collaborator

Source ClinicalTrials.gov
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