An observational study in Brain Injuries, Traumatic, Concussion, Brain and Concussion, Mild, sponsored by BrainScope Company, Inc.. Completed at 4 sites in United States. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by BrainScope Company, Inc. · Observational
This study (Part 2) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 177 is above the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →BrainScope Company, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Approximately 150 male and female student-athletes from participating high schools will be invited to participate.
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Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.
Exclusion Criteria:
Injured subjects consist of athletes who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, balance/sway measurement, and clinical symptoms/assessments. In addition, a subset of injured and matched control subjects will receive advanced MRI/DTI neuroimaging at time of injury and following RTP.
Device: BrainScope Ahead 200iD · Device: Advanced MRI Neuroimaging
This subject pool will consist of uninjured (not head injured) contact and non-contact athletes and will be tested at two time points - pre-season and post-season. These subjects will perform the same BrainScope Battery as the injured and matched control subjects at each time points.
Device: BrainScope Ahead 200iD
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
Also known as: Magnetic Resonance Imaging, Diffusion Tension Imaging
Algorithm for Likelihood of being concussed
Create a database of all assessments including brain electrical activity (EEG), neurocognitive performance, balance, and clinical/symptom assessments, to support derivation of a multimodal brain function/concussion index.
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Advanced Neuroimaging in concussion
Exploration of changes in functional neuroimaging which occur with concussion and change in these measures over time.
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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BrainScope Company, Inc.