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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03319966
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

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.

Condition or disease
Mild Traumatic Brain Injury Brain Concussion Convergence Insufficiency Accommodative Insufficiency Saccadic Eye Movement Deficiency Oculomotor Dysfunction

Detailed Description:

The primary objectives are: 1) To demonstrate that measurements from visual stimulus and eye tracking system will predict the presence or absence of traumatic brain injury related vision disorder, i.e. oculomotor dysfunction (OMD) as diagnosed by a developmental optometrist (OD). 2) To use the eye tracking visual measurements to predict the effectiveness of neurovision rehabilitation (NVR) on post-traumatic OMD by comparing the data obtained to the objective visual measurements found on the OD examination.

Mild traumatic brain injury (mTBI) that alters brain function is a major public health concern of significant personal and societal burden. Mild traumatic brain injury patients may experience any or all of at least 20 symptoms, with some persisting for weeks to months and increasing the risk of comorbidities. Current mTBI diagnosis and treatment are subjective and imprecise rather than objective and patient specific. Despite the varied heterogeneous manifestations of mTBI based on location and severity of injury as well as predisposing factors, treatment is generic and lacking in active therapies: rest with the avoidance of devices/screens to avoid exacerbating symptoms. This "one size fits all" approach is suboptimal, often resulting in ineffective management with prolonged inadequate recovery. Recent evidence suggests effective therapies to be specific to the mTBI patient and their symptoms with promising interventions targeting vestibular deficits as well as post-TBI OMD NVR. Neurovision rehabilitation is analogous to physical therapy for the eyes and improves the connection between the brain and the eyes with prior research finding NVR to be very effective for patients with post-concussion visual dysfunctions. Patients with potential mTBI primarily present to the emergency department, primary care, or specialty clinic, where there lacks proper equipment, training, and time for a comprehensive vision examination. Additionally, identification and diagnosis of OMD is only conducted currently by a vision specialist or highly skilled TBI specialists. This leaves a majority of OMD patients with inappropriate diagnosis and inadequate work or school accommodations as well as without treatment with NVR, lenses, and prisms. Thus an objective, easily accessible tool to identify mTBI related OMD would greatly advance clinical care.

This trial is a single center, longitudinal, pilot study. One hundred mTBI patients with OMD, confirmed with objective testing by a OD, who fit inclusion/exclusion criteria will be initially identified by providers at the Hennepin County Medical Center (HCMC) TBI Clinic. No subject will be excluded on the basis of sex/gender, race or ethnicity. If interested, subjects will be consented then undergo an initial eye tracking. Within two weeks of the initial eye tracking, subjects will begin recommended NVR with occupational therapists (OT) at HCMC. Each NVR session will assess each subject's progress and following each NVR session, subjects will receive an eye tracking test. Additionally, within two months of the initial OMD diagnosis patients will follow up with the OD every two months until their OMD is resolved or until one year following their diagnosis. Subjects will also undergo an eye tracking test after each OD follow up appointment. Eye tracking visual stimulus measurements will be compared to OD diagnostic measurements and assessments.

The goals of this research study are to improve objective, timely identification of mTBI related visual dysfunctions and assessment of the effectiveness of NVR. A positive outcome will greatly impact diagnosis and care of mTBI patients with vision dysfunction, as objective assessments will be more widely and readily available and NVR will be more utilized by the medical community. Overall post-mTBI functional outcomes will improve, significantly lessening this major public health concern affecting patients, families, communities, and society.

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : August 21, 2020
Actual Study Completion Date : August 21, 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Eye Tracker as an Objective Tool for "Yes/No" Assessment of Oculomotor Dysfunction Presence [ Time Frame: 12 months ]
    Eye tracker metrics of oculomotor dysfunction as compared to objective developmental optometry diagnostic measurements.

Secondary Outcome Measures :
  1. Eye Tracking Visual Measurements as Objective Predictor of Neurovision Rehabilitation Effectiveness [ Time Frame: 12 months ]
    Eye tracker metrics of oculomotor dysfunction status throughout neurovision rehabilitation as compared to objective developmental optometry follow up measurements and eye therapy exercise findings.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mild traumatic brain injury patients who meet the inclusion/exclusion criteria.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03319966

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United States, Minnesota
Hennepin County Medical Center Traumatic Brain Injury Clinic
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Hennepin Healthcare Research Institute
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Principal Investigator: Sarah Rockswold, MD Hennepin County Medical Center, Minneapolis
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Responsible Party: Hennepin Healthcare Research Institute Identifier: NCT03319966    
Other Study ID Numbers: HSR#17-4409
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Ocular Motility Disorders
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Cranial Nerve Diseases
Eye Diseases