Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University
RECRUITING
Boston
Time Frame
Start Date: 2023-08-15
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 60
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Rebiscan, Inc.
Collaborators: Boston Medical Center

This content was sourced from clinicaltrials.gov