Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes (CASVAL)

May 21, 2019 updated by: BrainScope Company, Inc.

Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes

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.

Study Overview

Detailed Description

EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT03671083 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point.

Study Type

Observational

Enrollment (Actual)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • University of Arkansas
    • Connecticut
      • Storrs, Connecticut, United States, 06269
        • University of Connecticut
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas - Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 220 male and female student-athletes from participating universities or colleges will be invited to participate.

Description

Inclusion Criteria (For Injured Subjects):

  1. Time of injury within 72 hours of BrainScope Battery
  2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
  3. No hospital admission due to either head injury or collateral injuries for >24 hours
  4. GCS between 13-15

Exclusion Criteria:

  1. Previously enrolled as an Injured or Matched Control subject in the BrainScope Algorithm Development Study
  2. 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)
  3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection
  4. History of brain surgery or neurological disease
  5. Pregnant women
  6. Do not speak or read English
  7. Loss of consciousness ≥ 20 minutes related to the concussion injury - for injured subjects only
  8. Prior history of concussion in the last year - for Matched Control subjects only

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likelihood of being concussed
Time Frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significance of change over time
Time Frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Significant difference in concussion index between time of injury and return to play (RTP)
6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Prediction of prolonged recovery
Time Frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index
6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2017

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

March 2, 2018

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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