mTBI Identification and Monitoring Through Retinal Scanning

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rebiscan, Inc.
Study ID
NCT06142435
Status
Recruiting
Apply to this trial

Conditions

  • Brain Injuries, Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 15, 2023
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Controls
    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.
  • Arm: TBI-Suspected Patients
    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.

Primary Outcome Measure

TBI Detection [ Time Frame: 1 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston UniversityBostonMassachusetts02215
Nathan Cardoos, MD
[email protected]
617-414-6800
Justin Shaka, MBA
[email protected]
857-600-0982

Find similar trials in Boston, MA

By research site
Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University· Boston, MA

Related Studies