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

BrainScope Company, Inc.420 enrolled

Overview

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.

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

420

Conditions

Brain Injuries, Traumatic Concussion, Mild Concussion, Brain Concussion, Severe Concussion, Intermediate

Interventions

BrainScope Ahead 200iDDEVICE

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

Sex: ALLMin age: 18 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Arkansas

Fayetteville, Arkansas, United States

University of Connecticut

Storrs, Connecticut, United States

University of South Florida

Tampa, Florida, United States

Michigan State University

East Lansing, Michigan, United States

Outcomes

Primary Outcomes

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)

Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP

Secondary Outcomes

Significance of change over time

Significant difference in concussion index between time of injury and return to play (RTP)

Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP

Prediction of prolonged recovery

Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index

Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP

Data from ClinicalTrials.gov

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