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.
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
- Conditions the study is for
- Mild Traumatic Brain Injury, Brain Concussion, Convergence Insufficiency
- 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
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.
- Conditions
- Mild Traumatic Brain Injury, Brain Concussion, Convergence Insufficiency, Accommodative Insufficiency, Saccadic Eye Movement Deficiency, Oculomotor Dysfunction
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted24 Oct 2017
- Study start18 Oct 2017
- Primary completion21 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Rockswold, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03319966
- Acronym / sponsor ID
- HSR#17-4409
- Conditions
- Mild Traumatic Brain Injury, Brain Concussion, Convergence Insufficiency, Accommodative Insufficiency, Saccadic Eye Movement Deficiency, Oculomotor Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Mild traumatic brain injury patients who meet the inclusion/exclusion criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Eye Tracking Visual Measurements as Objective Predictor of Neurovision Rehabilitation Effectiveness
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Rockswold, MD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
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.