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

NCT ID: NCT02957461

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2018-03-02

Brief Summary

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

BrainScope Ahead 200iD

Intervention Type: DEVICE

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.

BrainScope Ahead 200iD

Intervention Type: DEVICE

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.

Interventions

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 Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

BrainScope Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Prichep, Ph.D.

Role: STUDY_DIRECTOR

BrainScope Company, Inc.

Locations

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

University of Rochester Medical Center

Rochester, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of South Carolina

Columbia, South Carolina, United States

University of Texas - Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

18-Ahead

Identifier Type: -

Identifier Source: org_study_id