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



Status:Recruiting
Conditions:Hospital, Neurology, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:13 - 55
Updated:7/19/2018
Start Date:October 18, 2017
End Date:June 2019
Contact:Sey Lee
Email:sey.lee@hcmed.org
Phone:612-873-9494

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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.

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.

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.
We found this trial at
1
site
701 Park Avenue South
Minneapolis, Minnesota 55404
Phone: 612-873-8700
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Minneapolis, MN
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