Traumatic Brain InjuryNCT03761641
Pilot Study of NeuroTriage Device in Patients with Potential Brain Injury And/or Impairment
An observational study of Traumatic Brain Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This protocol is aimed at collecting oculomotor response data from a variety of brain injuries and impairments, and to secondarily evaluate the functionality and ease of use of the NeuroTriage device in the ED in patients with any presumed brain injury and/or impairment. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Neurotriage
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 15 Nov 2015
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to Parkland ED with suspected brain injury greater than 18 years of age, of an race or gender. Patients will need to be fluent in Spanish or English
Criteria for Inclusion of Subjects:
One hundred individuals presenting to Parkland Emergency Department, Zale Lipshy and Clements Hospital for treatment diagnosed to be any form of mild, moderate or severe TBI, between the ages of 18 and 65 will be given the opportunity to participate in this study.
Patients injury should have occurred within the past 24 hours,and have an acute brain CT performed based on clinical care. We will enroll patients presenting to the Emergency Department (ED) with a history of TBI as per American Congress of Rehabilitation Medicine(ACRM) Criteria, in which the patient has sustained a traumatically induced* physiological disruption of brain function, as manifested by ≥ one of the following:
- Any period of loss of consciousness (LOC)
- Any loss of memory for events (e.g. amnesia) immediately before or after the accident-
- Any alteration of mental state at the time of the accident (feeling dazed, disoriented, and/or confused)
- Focal neurologic deficits that may or may not be permanent
Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement (e.g. whiplash) without direct external trauma to the head.
All patients will need to be fluent in English or Spanish and be able to personally provide informed consent or have a legally authorized representative provide informed consent.
Individuals will not be excluded based on gender or race.
Criteria for Exclusion of Subjects:
Patients who have a penetrating Traumatic Brain Injury or a Spinal Cord Injury with ASIA score of C or worse will not be eligible for enrollment in this study.
- Any patients that are already participating in an interventional trial (e.g. drug, devise or behavioral) will be excluded.
- Non-English or Spanish speakers will be excluded.
- Any cognitive defect that limits comprehension of the study procedures and risks associated will be excluded.
- Patients with significant polytrauma that would interfere with assessments.
- Patients that have a significant history of pre-existing conditions that would interfere assessments (e.g.substance abuse, alcoholism, HIV/AIDS, major transmittable diseases that may interfere with consent, endstage cancers, learning disabilities, and developmental disorders).
- Patients on psychiatric hold or patients with a major debilitating mental health disorder (e.g. schizophrenia or bipolar disorder) will be excluded as they may interfere with follow-up and the validity of assessments.
- Patients with major debilitating neurological disease (e.g. stroke, CVA, dementia, tumor) impairing baseline awareness,cognition, or validity of follow-up and outcome assessment.
- Pregnancy in female subjects and prisoners in custody will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol is aimed at collecting oculomotor response data from a variety of brain injuries and impairments, and to secondarily evaluate the functionality and ease of use of the NeuroTriage device in the ED in patients with any presumed brain injury and/or impairment. For example, prior studies in adolescents with a concussion have shown that they tend to overshoot the pattern when asked to follow the movement of the lights in the binoculars
Read the detailed description
Study personnel will identify potential subjects in the ED, hospital and ICU during "peak hours" as appropriate through conferring with medical records, trauma logs, triage notes, and head CT, MRI, and other brain imaging orders as well as on-duty doctors and nurses to identify potential subjects. Many of the inclusion/exclusion criteria can be evaluated by a review of the potential subject's medical records, such as mechanism of injury or impairment, extent of non-head injuries, prior medical history, and prior clinical visits at the center of care. When a potential subject is identified and has been screened against the primary set of inclusion/exclusion criteria, they will be approached about the study.
Prior to enrolling a subject, the research personnel will screen the subject for competency to provide informed consent. This is necessary because, by its very nature, suspected brain injury patients may or may not be able to initially provide informed consent. The Galveston Orientation and Amnesia Test (GOAT) will be used as the standard assessment instrument for this screening. A score of 75 or greater on the GOAT would indicate that the subject is competent to provide informed consent. If the subject scores < 75 on the GOAT, then consent must be provided by a Legally Authorized Representative (LAR). This is a threshold of competency that has been used in previous studies here at UTSW.
Potential subjects that pass the GOAT will be given time to read the Consent Form and to consult with family members who may be present or by phone. If the subject agrees to participate, then they will sign the appropriate forms. A copy of the form will be given to the subject. The NeuroTriage and GOAT will then be serially performed on the patient no more than once every two hours (particularly in the ED, where the stay is often short) or with changes in neurological status.
- Conditions
- Traumatic Brain Injury
- Being tested
- Neurotriage
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurotriageOther
NeuroTriage binocular handset monitors pupil dynamics \& eye position with infrared cameras. Rubber non-allergenic ocular spacers contoured to eye sockets come in contact with the face \&cushion between the skin \& eyepiece. During pupil dilation tests, an LED briefly illuminates the pupil. The NeuroTriage system measures neurological pupil index, constriction velocity, \& dilation velocity. Total pupil dilation testing time is < 1 minute. During saccade-tracking tests, patients direct their gaze towards dim LED targets selectable across the range of view. Visual targets involve center-out ocular motion or smooth pursuit following of illusory movement. The NeuroTriage system measures eye position \& movement velocity during these tests. Total saccade-tracking testing takes < 3 minutes. Ocular measures are non-invasive, are done quickly and commonly used to measure neurological function.
What is being measured
The primary outcome is the main question the study is designed to answer.
Calibration of Neurotriage Device
Evaluate the number of rehabilitation device failure as reported by study team
Measured: Through study completion, 1 year
Enjoyment of Neurotriage Device Use
Assess feasibility, ease of use and enjoyment for device in injured population. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware, changes will be made based on feedback received from participants.
Measured: Through Study Completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study startMar 2015
- Primary completion15 Nov 2015
- Study completion15 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Wigginton, University of Texas Southwestern Medical Center
- Investigators
- Jane G Wigginton, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761641
- Sponsor's protocol ID
- 012015-030
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2015
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of NeuroTriage Device in Patients with Potential Brain Injury And/or Impairment
- ClinicalTrials.gov ID
- NCT03761641
- Acronym / sponsor ID
- 012015-030
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 15 Nov 2015 (actual)
- Study completion
- 15 Nov 2015 (actual)
- First posted
- 3 Dec 2018 (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.
This protocol is aimed at collecting oculomotor response data from a variety of brain injuries and impairments, and to secondarily evaluate the functionality and ease of use of the NeuroTriage device in the ED in patients with any presumed brain injury and/or impairment. For example, prior studies in adolescents with a concussion have shown that they tend to overshoot the pattern when asked to follow the movement of the lights in the binoculars
Detailed description
Study personnel will identify potential subjects in the ED, hospital and ICU during "peak hours" as appropriate through conferring with medical records, trauma logs, triage notes, and head CT, MRI, and other brain imaging orders as well as on-duty doctors and nurses to identify potential subjects. Many of the inclusion/exclusion criteria can be evaluated by a review of the potential subject's medical records, such as mechanism of injury or impairment, extent of non-head injuries, prior medical history, and prior clinical visits at the center of care. When a potential subject is identified and has been screened against the primary set of inclusion/exclusion criteria, they will be approached about the study.
Prior to enrolling a subject, the research personnel will screen the subject for competency to provide informed consent. This is necessary because, by its very nature, suspected brain injury patients may or may not be able to initially provide informed consent. The Galveston Orientation and Amnesia Test (GOAT) will be used as the standard assessment instrument for this screening. A score of 75 or greater on the GOAT would indicate that the subject is competent to provide informed consent. If the subject scores < 75 on the GOAT, then consent must be provided by a Legally Authorized Representative (LAR). This is a threshold of competency that has been used in previous studies here at UTSW.
Potential subjects that pass the GOAT will be given time to read the Consent Form and to consult with family members who may be present or by phone. If the subject agrees to participate, then they will sign the appropriate forms. A copy of the form will be given to the subject. The NeuroTriage and GOAT will then be serially performed on the patient no more than once every two hours (particularly in the ED, where the stay is often short) or with changes in neurological status.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to Parkland ED with suspected brain injury greater than 18 years of age, of an race or gender. Patients will need to be fluent in Spanish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurotriageNeuroTriage binocular handset monitors pupil dynamics \& eye position with infrared cameras. Rubber non-allergenic ocular spacers contoured to eye sockets come in contact with the face \&cushion between the skin \& eyepiece. During pupil dilation tests, an LED briefly illuminates the pupil. The NeuroTriage system measures neurological pupil index, constriction velocity, \& dilation velocity. Total pupil dilation testing time is < 1 minute. During saccade-tracking tests, patients direct their gaze towards dim LED targets selectable across the range of view. Visual targets involve center-out ocular motion or smooth pursuit following of illusory movement. The NeuroTriage system measures eye position \& movement velocity during these tests. Total saccade-tracking testing takes < 3 minutes. Ocular measures are non-invasive, are done quickly and commonly used to measure neurological function. | Other | – |
Primary outcome
Calibration of Neurotriage Device
Time frame: Through study completion, 1 year
Evaluate the number of rehabilitation device failure as reported by study team
Enjoyment of Neurotriage Device Use
Time frame: Through Study Completion, 1 year
Assess feasibility, ease of use and enjoyment for device in injured population. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware, changes will be made based on feedback received from participants.
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 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Jane G Wigginton, MD principal investigator
University of Texas Southwestern Medical Center
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 Traumatic Brain Injury, run by University of Texas Southwestern Medical Center 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?
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 15 Oct 2024. 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?
Calibration of Neurotriage Device (time frame: Through study completion, 1 year). The study lists 2 primary outcomes in all. 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 15 Oct 2024.