mTBI Identification and Monitoring Through Retinal Scanning

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rebiscan, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of 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

Inclusion Criteria

You can understand and agree to participate in the study.

If you are under 18 years old, you need permission from your parents or guardians to participate.

You can understand and follow simple instructions during the examination.

Treatment Details

Participant Groups

Group I: TBI-Suspected Patients Experimental Treatment 1 Intervention

TBI participants 18-45 years of age, recruited from patients at a clinical research facility who present with head trauma. Clinical evaluation for the patient can be positive (target condition present) or negative (target condition absent) for mTBI. Testing will occur on Day-0, Day-14, and Day-30.

Group II: Controls Experimental Treatment 1 Intervention

Participants should not be part of the Intended Use Population. Subjects that present to the hospital, clinic, or emergency department, either as a patient or non-patient, with no history of head trauma and, are 18-45 years of age.

Who Is Running the Clinical Trial?

Rebiscan, Inc.

Lead Sponsor

Trials

10

Recruited

1,300+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+