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

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ClinicalTrials.gov Identifier: NCT02957461
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
BrainScope Company, Inc.

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.

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Concussion, Mild Concussion, Brain Concussion, Severe Concussion, Intermediate Device: BrainScope Ahead 200iD

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.

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Study Type : Observational
Actual Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes
Actual Study Start Date : February 3, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : March 2, 2018

Group/Cohort Intervention/treatment
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.
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 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.
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 Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 220 male and female student-athletes from participating universities or colleges will be invited to participate.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957461


Locations
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United States, Arkansas
University of Arkansas
Fayetteville, Arkansas, United States, 72701
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
United States, Texas
University of Texas - Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
BrainScope Company, Inc.
United States Department of Defense
Investigators
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Study Director: Leslie Prichep, Ph.D. BrainScope Company, Inc.

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Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT02957461     History of Changes
Other Study ID Numbers: 18-Ahead
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: August 2018
Keywords provided by BrainScope Company, Inc.:
Concussion
Mild Traumatic Brain Injury
Sport Related Concussion
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating