ClinicalTrials.gg
CompletedNCT03319966Updated Oct 19, 2020

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

An observational study in Mild Traumatic Brain Injury, Brain Concussion and Convergence Insufficiency, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 13 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Hennepin Healthcare Research Institute · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
92
Ages
13 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 418 studies in Brain Concussion with a site in United States — 100 open to participants now, 121 under way, 5 of them phase 3. Brain Concussion · United States.

Enrollment
61st of 96
92 · median 147
Started
2017
with 24 others
Observational
96 of 418
17 open now
Registered
168th of 418
by date

Among the 418 studies in Brain Concussion with a site in United States, this one is the 61st largest by enrollment of the 96 observational ones that give a count, is one of 25 that started in 2017, is one of 96 observational ones, and was the 168th registered.

Brain Concussion

639 studies on the registry are indexed under Brain Concussion; 165 are open to participants now.

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Open to participants now

100 of the 418 studies in Brain Concussion with a site in United States are open now. Recruiting first, the newest first:

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A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 112 Brain Concussion studies recruiting now, 33 (29%) set no upper age limit and 72 (64%) stop at 75 or younger; 24 take children under 18; 38 take healthy volunteers.

This study: 13 Years to 55 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Mild Traumatic Brain Injury
  • Brain Concussion
  • Convergence Insufficiency
  • Accommodative Insufficiency
  • Saccadic Eye Movement Deficiency
  • Oculomotor Dysfunction
04

Who can participate

Ages eligible
13 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • obtained

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
92 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. Eye Tracking Visual Measurements as Objective Predictor of Neurovision Rehabilitation Effectiveness

    Eye tracker metrics of oculomotor dysfunction status throughout neurovision rehabilitation as compared to objective developmental optometry follow up measurements and eye therapy exercise findings.

    Time frame: 12 months

07

Study locations

1 site
  • Hennepin County Medical Center Traumatic Brain Injury Clinic
    Minneapolis, Minnesota 55404, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Aug 2020, 34 months.

Of 72 non-industry observational studies under Brain Concussion, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 188. This study's 34 months is close to that.

Counting every sponsor, half of 94 studies reached it within 35 months; a quarter within 16 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2017
First posted
Oct 24, 2017
StartActual
Oct 18, 2017
Primary completionActual
Aug 21, 2020
CompletionActual
Aug 21, 2020
Last update
Oct 19, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03319966
Lead sponsor
Hennepin Healthcare Research Institute
Responsible party
Sponsor
First posted
Oct 24, 2017
Start date
Oct 18, 2017
Primary completion
Aug 21, 2020
Completion
Aug 21, 2020
Last update
Oct 19, 2020

Study contacts

Sarah Rockswold, MD
principal investigator · Hennepin County Medical Center, Minneapolis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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