Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
AheadCAS-HS
1 other identifier
observational
177
1 country
4
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2016
CompletedFirst Posted
Study publicly available on registry
January 22, 2016
CompletedStudy Start
First participant enrolled
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedMay 23, 2019
May 1, 2019
1 year
January 19, 2016
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary Outcomes (1)
Advanced Neuroimaging in concussion
6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Study Arms (2)
Injured and Matched Control Subject Pool
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.
Pre-Season and Post-Season Subject Pool
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.
Interventions
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.
Eligibility Criteria
Approximately 150 male and female student-athletes from participating high schools will be invited to participate.
You may qualify if:
- 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.
- If loss of consciousness, total duration less than \<20 minutes
- No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
- No hospital admission due to either head injury or collateral injuries for \>24 hours.
- GCS between 13-15
You may not qualify if:
- Do not speak or read English
- Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
- Skull abnormalities, e.g. metal plate
- History of brain surgery or neurological disease
- Pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Arkansas
Fayetteville, Arkansas, 72701, United States
Walt Whitman High School
Bethesda, Maryland, 20817, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (1)
Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31.
PMID: 32228157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Leslie Prichep, Ph.D.
BrainScope Company, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2016
First Posted
January 22, 2016
Study Start
January 29, 2016
Primary Completion
January 31, 2017
Study Completion
July 31, 2017
Last Updated
May 23, 2019
Record last verified: 2019-05