Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

Brain Injuries Clinical Trial

— DETECT  

Official title:

Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776462
• Other study ID #: DETECT TBI001
• Status: Completed
• Start date: June 2016
• Est. completion date: June 19, 2018

Study information

• Verified date: September 2018
• Source: Oculogica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: June 19, 2018
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 67 Years

Eligibility

Inclusion Criteria:

• Provide written informed consent.

• Be between the ages of 4 and 67 years old.

• Have a diagnosis of traumatic brain injury with a potential for concussion.

• Subjects must have baseline vision correctable to within 20/500 bilaterally.

• Subjects must have intact ocular motility.

• Subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior.

Exclusion Criteria:

• ER visit has been more than 2 weeks since the injury which may have caused the concussion.

• Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).

• Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability.

• Blind (no light perception), are missing eyes, do not open eyes.

• It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.

• Previous history of: ocular motility dysfunction or extensive prior eye surgery.

• Any physical or mental injury or baseline disability rendering task completion difficult.

• Obvious intoxication or blood alcohol level greater than 0.2.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Concussion
• Concussion, Intermediate
• Concussion, Mild
• Concussion, Severe
• Craniocerebral Trauma
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Device:
• EyeBox CNS

Locations

Country	Name	City	State
United States	Beaver Dam Community Hospital	Beaver Dam	Wisconsin
United States	SkyRidge Medical Center	Lone Tree	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Oculogica, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12. — View Citation

Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6. — View Citation

Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change in metrics of eye movement that enable positive concussion detection using BOX Score.	A True Positive rate for identifying Concussion as compared to a Clinical Reference standard.	Immediately after eye tracking, within 2 weeks of injury
Secondary	Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion.		Immediately before eye tracking, between 1 week and 109 weeks post injury