Pilot Study of NeuroTriage Device in Patients With Potential Brain Injury and/or Impairment
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|ClinicalTrials.gov Identifier: NCT03761641|
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury||Other: Neurotriage|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Pilot Study of NeuroTriage Device in Patients With Potential Brain Injury and/or Impairment|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
- Other: Neurotriage
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761641
|Contact: Victoria S Warren, RNemail@example.com|
|United States, Texas|
|Parkland Memorial Hospital||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Victoria S Warren, RN 214-648-2523 firstname.lastname@example.org|
|Principal Investigator:||Jane G Wigginton, MD||University of Texas Southwestern Medical Center|