mTBI Identification and Monitoring Through Retinal Scanning

NCT06142435 | Recruiting DMC FDA Device

• 1 other identifier: BU-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

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.

  1 day

Secondary Outcomes (2)

• TBI Monitor

  14 days

• TBI Monitor

  30 days

Study Arms (2)

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.

Device: Head and Intraocular Trauma Tool

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.

Device: Head and Intraocular Trauma Tool

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.

Also known as: HITT

Controls; TBI-Suspected Patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Able to participate in the examination, including the ability to follow simple instructions
• Fluency in English or Spanish

You may not qualify if:

• 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
• Known strabismus, amblyopia (lazy eye), or double vision
• Known eye movement disorder, including nystagmus
• Known optic nerve disease, including papilledema or optic neuropathy
• Known retinal disease, including macular degeneration or retinal degeneration
• Known cataract
• History of neurosurgery
• History of stroke/brain hemorrhage, brain tumor, or epilepsy
• Any head trauma requiring medical attention from a physician within the last 6 months
• Diagnosed dementia or cognitive impairment requiring assistance for daily living
• Other condition(s) under the care of a neurologist
• Psychiatric hospitalization in the last 90 days

Sponsors & Collaborators

• Rebiscan, Inc.: lead
• Boston Medical Center: collaborator

Study Sites (1)

Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be drawn by venipuncture, collected in Serum Separator Tubes, clotted for 30-60 min, centrifuged at 1,500 rpm for 15 min, and stored at -80°C until batch analysis for serum levels of four well-established brain injury biomarkers (i.e., astrocyte-derived glial fibrillary acidic protein; GFAP; neuron-derived ubiquitin carboxy-terminal hydrolyzing enzyme L1, UCH-L1; neuron-derived total microtubule-associated protein tau, T-Tau; neuron-derived neurofilament-light chain, NF-L) using the Quanterix SIMOA Neurology 4-plex "B" kit.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 21, 2023
• Study Start: August 15, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be shared on an ongoing basis, and cumulatively at the end of the study. Study length is expected to be 2 months from the first enrolled participant.
• Access Criteria: Data will only be shared with researchers involved in the study at the Boston Medical Center, and only trained staff members at the device manufacturer.

Locations

US (1)