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

Completed

• Conditions: Concussion, Severe; Concussion, Intermediate; Brain Injuries, Traumatic; Concussion, Mild; Concussion, Brain
• Interventions: Device: BrainScope Ahead 200iD; Device: Advanced MRI Neuroimaging

• Registration Number: NCT02661633
• Lead Sponsor: BrainScope Company, Inc.

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).

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 Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-22
• Study Start: 2016-01-29
• Primary Completion: 2017-01-31
• Study Completion: 2017-07-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Injured and Matched Control Subject Pool	Advanced MRI Neuroimaging	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.
Injured and Matched Control Subject Pool	BrainScope Ahead 200iD	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	BrainScope Ahead 200iD	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.

Primary Outcome Measures

Name	Time	Method
Algorithm for Likelihood of being concussed	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.

Secondary Outcome Measures

Name	Time	Method
Advanced Neuroimaging in concussion	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.

Trial Locations

Locations (4)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States

Walt Whitman High School; 🇺🇸 Bethesda, Maryland, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Michigan State University; 🇺🇸 East Lansing, Michigan, United States