Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
CASVAL
1 other identifier
observational
420
1 country
8
Brief Summary
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 years) for the final analyses of validation of the algorithms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
8 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
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedStudy Start
First participant enrolled
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2018
CompletedMay 23, 2019
August 1, 2018
12 months
November 3, 2016
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Likelihood of being concussed
Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI)
6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary Outcomes (2)
Significance of change over time
6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Prediction of prolonged recovery
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, ocular motor assessment, and clinical symptoms/assessments.
Healthy Volunteer Subject Pool
This subject pool will consist of uninjured (not head injured) contact and non-contact athletes and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects.
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 Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG.
Eligibility Criteria
Approximately 220 male and female student-athletes from participating universities or colleges will be invited to participate.
You may qualify if:
- Time of injury within 72 hours of BrainScope Battery
- 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:
- Previously enrolled as an Injured or Matched Control subject in the BrainScope Algorithm Development Study
- Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD)
- Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection
- History of brain surgery or neurological disease
- Pregnant women
- Do not speak or read English
- Loss of consciousness ≥ 20 minutes related to the concussion injury - for injured subjects only
- Prior history of concussion in the last year - for Matched Control subjects only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BrainScope Company, Inc.lead
- United States Department of Defensecollaborator
Study Sites (8)
University of Arkansas
Fayetteville, Arkansas, 72701, United States
University of Connecticut
Storrs, Connecticut, 06269, United States
University of South Florida
Tampa, Florida, 33612, United States
Michigan State University
East Lansing, Michigan, 48824, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
University of South Carolina
Columbia, South Carolina, 29208, United States
University of Texas - Austin
Austin, Texas, 78712, United States
MeSH Terms
Conditions
Condition 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
November 3, 2016
First Posted
November 7, 2016
Study Start
February 3, 2017
Primary Completion
January 31, 2018
Study Completion
March 2, 2018
Last Updated
May 23, 2019
Record last verified: 2018-08