Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06142435
Other study ID # BU-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2023
Est. completion date August 31, 2024

Study information

Verified date November 2023
Source Rebiscan, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 4. Able to participate in the examination, including the ability to follow simple instructions 5. 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Rebiscan, Inc. Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 TBI Monitor 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. 14 days
Secondary TBI Monitor 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. 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT04111549 - GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth N/A
Recruiting NCT05097261 - Ketamine in Acute Brain Injury Patients. Phase 4
Completed NCT03504709 - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Completed NCT05057377 - Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
Withdrawn NCT02776488 - Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI) Phase 2
Completed NCT02426749 - Treatment and Recovery Monitoring of Post TBI Symptoms N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting NCT05977270 - The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury N/A
Recruiting NCT04666766 - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers N/A
Active, not recruiting NCT04559724 - Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes N/A
Not yet recruiting NCT04515420 - The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
Not yet recruiting NCT05569993 - Glutamine and Traumatic Brain Injury Early Phase 1
Recruiting NCT04331392 - Online Memory Intervention for Individuals With Traumatic Brain Injury N/A
Completed NCT03727737 - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT02004080 - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed NCT01336413 - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans Phase 2
Completed NCT04957563 - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia N/A
Completed NCT05179330 - Visual Feedback in Lower Limb Rehabilitation N/A