Objective Brain Function Assessment of mTBI/Concussion in College Athletes

Brain Injuries, Traumatic Clinical Trial

— AheadCAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477943
• Other study ID #: 14-Ahead
• Status: Completed
• Start date: August 8, 2015
• Est. completion date: July 31, 2017

Study information

• Verified date: May 2019
• Source: BrainScope Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study (Part 1) 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: July 31, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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 is between 13-15.

Exclusion Criteria:

1. Evidence of illicit drug usage

2. Do not speak or read English

3. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)

4. Skull abnormalities, e.g. metal plate

5. History of brain surgery or neurological disease.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Texas - Austin	Austin	Texas
United States	University of South Carolina	Columbia	South Carolina
United States	Michigan State University	East Lansing	Michigan
United States	University of Arkansas	Fayetteville	Arkansas
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Connecticut	Storrs	Connecticut
United States	SUNY Upstate Medical University	Syracuse	New York
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
BrainScope Company, Inc.	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algorithm for Likelihood of being concussed	Create a database of brain electrical activity (EEG) and clinical information collected from athletes who sustain a concussion during organized sports.	6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Secondary	Advanced Neuroimaging in concussion	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