mTBI Identification and Monitoring Through Retinal Scanning

• Sponsor: Rebiscan, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06142435
• Collaborator: Boston Medical Center (Other)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 12.6
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries, Traumatic	Device: Head and Intraocular Trauma Tool

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning
• Actual Study Start Date: Aug 15, 2023
• Anticipated Primary Completion Date: Aug 31, 2024
• Anticipated Study Completion Date: Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; 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.; Other Names: HITT
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; 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.; Other Names: HITT

Outcome Measures

Primary Outcome Measures

1. TBI Detection [1 day]

   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.

Secondary Outcome Measures

1. TBI Monitor [14 days]

   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.

2. TBI Monitor [30 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 18-45 years

2. Presents to the facility within 2 weeks of head trauma

3. Able to provide informed consent

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

1. Able to participate in the examination, including the ability to follow simple instructions

2. Fluency in English or Spanish

Exclusion Criteria:

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

2. Under the influence of alcohol or drugs

3. Previous eye surgery

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

5. Known strabismus, amblyopia (lazy eye), or double vision

6. Known eye movement disorder, including nystagmus

7. Known optic nerve disease, including papilledema or optic neuropathy

8. Known retinal disease, including macular degeneration or retinal degeneration

9. Known cataract

10. History of neurosurgery

11. History of stroke/brain hemorrhage, brain tumor, or epilepsy

12. Any head trauma requiring medical attention from a physician within the last 6 months

13. Diagnosed dementia or cognitive impairment requiring assistance for daily living

14. Other condition(s) under the care of a neurologist

15. Psychiatric hospitalization in the last 90 days

16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff

17. Any minor brain injury regardless of loss of consciousness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Rebiscan, Inc.
• Boston Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rebiscan, Inc.
• ClinicalTrials.gov Identifier: NCT06142435
• Other Study ID Numbers: BU-001
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

No Results Posted as of Nov 21, 2023