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Objective Brain Function Assessment of mTBI/Concussion in High School Athletes | Clinical Trials | Clareo Health

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Objective Brain Function Assessment of mTBI/Concussion in High School Athletes

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

NCT02661633•BrainScope Company, Inc.

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

13 - 19 years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

University of Arkansas

Fayetteville, Arkansas, United States

Walt Whitman High School

Bethesda, Maryland, United States

Michigan State University

East Lansing, Michigan, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

January 29, 2016

Primary Completion Date

January 31, 2017

Completion Date

July 31, 2017

Last Updated

May 23, 2019

Enrollment

177

ACTUAL participants

Conditions

Brain Injuries, TraumaticConcussion, BrainConcussion, MildConcussion, IntermediateConcussion, Severe

Interventions

BrainScope Ahead 200iD

DEVICE

Advanced MRI Neuroimaging

DEVICE

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

NCT05663034

Traumatic Brain InjuryInsomnia+8 more

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RECRUITINGNA

Facilitating Access to Specialty Treatment

NCT05741411

Mild Traumatic Brain InjuryConcussion, Mild+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Objective Brain Function Assessment of mTBI/Concussion in High School Athletes

Inclusion Criteria

Exclusion Criteria

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Facilitating Access to Specialty Treatment

BCAAs in Concussion 2.0

Online Memory Intervention for Individuals with Traumatic Brain Injury

The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms

The HOME Program for Individuals With Traumatic Brain Injury and Family Members