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Completed

NCT Number: NCT02957461

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

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.

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Key information

Conditions

Brain Injuries, Traumatic Brain Concussion Brain Diseases Brain Injuries Central Nervous System Diseases Concussion, Brain Concussion, Intermediate Concussion, Mild Concussion, Severe Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

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

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(For Injured Subjects):

  • Time of injury within 72 hours of BrainScope Battery
  • 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 between 13-15

Exclusion criteria

  • Previously enrolled as an Injured or Matched Control subject in the BrainScope Algorithm Development Study
  • 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)
  • Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection
  • History of brain surgery or neurological disease
  • Pregnant women
  • Do not speak or read English
  • Loss of consciousness ≥ 20 minutes related to the concussion injury - for injured subjects only
  • Prior history of concussion in the last year - for Matched Control subjects only

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

Primary outcomes

  1. Likelihood of being concussed

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

    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)

Secondary outcomes

  1. Significance of change over time

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

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

  2. Prediction of prolonged recovery

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

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

Sponsors and collaborators

Lead sponsor

BrainScope Company, Inc.

Industry

Collaborators

  • United States Department of Defense

Registry information

Official study title

Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes

Acronym: CASVAL

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2016
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.

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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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