Objective Brain Function Assessment of mTBI/Concussion in High School Athletes (AheadCAS-HS)

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

Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in High School Athletes

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

177

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

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • University of Arkansas
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Walt Whitman High School
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

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

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 150 male and female student-athletes from participating high schools will be invited to participate.

Description

Inclusion Criteria:

  • 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.

    1. If loss of consciousness, total duration less than <20 minutes
    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. Do not speak or read English
  2. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
  3. Skull abnormalities, e.g. metal plate
  4. History of brain surgery or neurological disease
  5. Pregnant women.

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, 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
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.
Device: Advanced MRI Neuroimaging
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.
Other Names:
  • Magnetic Resonance Imaging
  • Diffusion Tension Imaging
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Advanced Neuroimaging in concussion
Time Frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Exploration of changes in functional neuroimaging which occur with concussion and change in these measures over time.
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.

Sponsor

BrainScope Company, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 29, 2016

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-Ahead

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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