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Completed

NCT Number: NCT02477943

Objective Brain Function Assessment of mTBI/Concussion in College Athletes

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).

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas, Fayetteville, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • If loss of consciousness, total duration less than <20 minutes
  • No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
  • No hospital admission due to either head injury or collateral injuries for >24 hours.
  • GCS is between 13-15.

Exclusion criteria

  • Evidence of illicit drug usage
  • Do not speak or read English
  • Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
  • Skull abnormalities, e.g. metal plate
  • History of brain surgery or neurological disease.

Treatment and study plan

BrainScope Ahead 200iD

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 a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.

Advanced MRI Neuroimaging

Device

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.

Other names: Magnetic Resonance Imaging, Diffusion Tension Imaging

Primary outcomes

  1. Algorithm for Likelihood of being concussed

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

    Create a database of brain electrical activity (EEG) and clinical information collected from athletes who sustain a concussion during organized sports.

Secondary outcomes

  1. Advanced Neuroimaging in concussion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

BrainScope Company, Inc.

Industry

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: AheadCAS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2015
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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