AzTrials
AzTrials

Mild Traumatic Brain InjuryNCT03319966

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

An observational study of Mild Traumatic Brain Injury and Brain Concussion, run by Hennepin Healthcare Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 to 55 years
How many people
92 participants
Where
1 siteUnited States
Study dates
18 Oct 2017to 21 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hennepin County Medical Center Traumatic Brain Injury Clinic

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

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.

Medical subject headings
Brain Concussion, Ocular Motility Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03319966
Study groupRoleWhat they receive
Oculomotor DysfunctionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (1)
  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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2017
  2. Study start18 Oct 2017
  3. Primary completion21 Aug 2020
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03319966
Sponsor's protocol ID
HSR#17-4409
Status last verified
Oct 2020
First submitted
19 Oct 2017
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Traumatic Brain Injury and Brain Concussion, run by Hennepin Healthcare Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eye Tracker as an Objective Tool for "Yes/No" Assessment of Oculomotor Dysfunction Presence (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in