Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury

NCT03319966 | Completed

• 1 other identifier: HSR#17-4409
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this single center, longitudinal, pilot study is to provide evidence for the use of an eye tracking system as an objective tool to identify mild traumatic brain injury (mTBI) related oculomotor dysfunction (OMD) and predict the effectiveness of neurovision rehabilitation (NVR) of OMD. Eye tracking visual stimulus measurements will be compared to objective developmental optometrist (OD) diagnosis and assessments. It will be determined whether an eye tracking system can predict the presence or absence of mTBI related OMD and whether mTBI patients who have OMD based on the eye tracking system will respond positively to NVR.

Conditions

Mild Traumatic Brain Injury; Brain Concussion; Convergence Insufficiency; Accommodative Insufficiency; Saccadic Eye Movement Deficiency; Oculomotor Dysfunction

Outcome Measures

Primary Outcomes (1)

• Eye Tracker as an Objective Tool for "Yes/No" Assessment of Oculomotor Dysfunction Presence

  Eye tracker metrics of oculomotor dysfunction as compared to objective developmental optometry diagnostic measurements.

  12 months

Secondary Outcomes (1)

• Eye Tracking Visual Measurements as Objective Predictor of Neurovision Rehabilitation Effectiveness

  12 months

Study Arms (1)

Oculomotor Dysfunction

This group consists of subjects with mTBI who have been diagnosed with OMD by objective OD measurements. These subjects will undergo neurovision rehabilitation used to treat oculomotor dysfunction following traumatic brain injury per usual clinical standard of care at the HCMC TBI Clinic.

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mild traumatic brain injury patients who meet the inclusion/exclusion criteria.

You may qualify if:

• Mild traumatic brain injury (Glasgow Coma Scale ≥ 13)
• Post traumatic amnesia \< 24 hours
• Diagnosed with oculomotor dysfunction by developmental optometrist and neurovision rehabilitation recommended
• Time of traumatic brain injury ≤ 2 years
• Informed consent obtained

You may not qualify if:

• Glasgow Coma Scale \< 13
• Age \< 13 years and \> 55 years
• Time of traumatic brain injury \> 2 years
• Cranial nerve II, III, IV, or VI palsy
• History of strabismus
• Monocular vision, including Lasik surgery for monofixation
• Taking medications known to interfere with visual process/recovery
• Taking illicit drugs such as marijuana, cocaine, heroin, etc.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center Traumatic Brain Injury Clinic

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Brain Concussion; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Sarah Rockswold, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: October 18, 2017
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)