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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by BrainScope Company, Inc.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
BrainScope Company, Inc.
ClinicalTrials.gov Identifier:
NCT02957461
First received: November 3, 2016
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
This study is designed to validate the performance of the algorithms to be used in future commercial device.

Condition Intervention
Brain Injuries, Traumatic
Brain Injury Without Open Intracranial Wound
Device: BrainScope Battery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes

Resource links provided by NLM:


Further study details as provided by BrainScope Company, Inc.:

Primary Outcome Measures:
  • Sensitivity and specificity of the identification of the likelihood of mTBI at the time of injury, compared to the standard of care diagnosis of concussion. [ Time Frame: Participants will be followed an expected average of 55 days. ]

Estimated Enrollment: 220
Study Start Date: January 2017
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Injured/Control Pool
Injured/Control Pool consisting of athletes who are injured during the season and matched control athletes.The athlete's in this pool will be tested with the study device at time of injury and 2 follow-up time points. The BrainScope Battery consists of 4 components to collect brain electrical activity, a cognitive assessment, a neurocognitive/symptom/balance assessment, and an ocular motor assessment.
Device: BrainScope Battery
The BrainScope Battery consists of 4 components to collect brain electrical activity, a cognitive assessment, a neurocognitive/symptom/balance assessment, and an ocular motor assessment.

Detailed Description:

Performance will be assessed by comparing the output of the algorithms, which were developed by correlating changes in brain electrical activity (EEG) and other measures of brain function to mTBI (e.g. concussion) in the sports environment.

Injured athletes will be studied during the season at time of injury, and then longitudinally weeks after injury. Matched controls will be tested following the same schedule as the injured athletes.

  Eligibility

Ages Eligible for Study:   18 Years to 29 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:

    • Age 18 - 29 years old
    • Time of injury within 72 hours of BrainScope Battery - for injured subjects
    • No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment) - for injured subjects
    • No hospital admission due to either head injury or collateral injuries for >24 hours - for injured subjects
  • Exclusion Criteria:

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02957461

Contacts
Contact: Douglas C Oberly 2407527680 ext 1015 doug.oberly@brainscope.com
Contact: Caroline Kim 2407527680 ext 1033 caroline.kim@brainscope.com

Locations
United States, Arkansas
University of Arkansas Not yet recruiting
Fayetteville, Arkansas, United States, 72701
Contact: Robert J Elbin, PhD    479-575-5262    rjelbin@uark.edu   
United States, Connecticut
University of Connecticut Not yet recruiting
Storrs, Connecticut, United States, 06269
Contact: Douglas Casa, PhD    860-429-7720    douglas.casa@uconn.edu   
Contact: Samm Scarneo, MS, ATC    860-486-0265    samantha.scarneo@uconn.edu   
United States, Florida
University of South Florida Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Gianluca Del Rossi    813-396-9094      
United States, Michigan
Michigan State University Not yet recruiting
East Lansing, Michigan, United States, 48824
Contact: Tracey Covassin, PhD    517-353-2010    covassin@msu.edu   
United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Contact: Kian Merchant-Borna    585-275-2909      
SUNY Upstate Medical University Not yet recruiting
Syracuse, New York, United States, 13210
Contact: Christopher Neville, PhD    315-464-9966    nevillec@upstate.edu   
Contact: Joshua Baracks, ATC    315-464-9966    baracksj@upstate.edu   
United States, South Carolina
University of South Carolina Not yet recruiting
Columbia, South Carolina, United States, 29208
Contact: Susan Yeargin, Ph.D., ATC    803-777-3169    syeargin@mailbox.sc.edu   
United States, Texas
University of Texas - Austin Not yet recruiting
Austin, Texas, United States, 78712
Contact: David Schnyer, PhD    512-475-8499    schnyer@utexas.edu   
Houston Methodist Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Kenneth Podell, Ph.D., FACPN    713-441-8914    kpodell@houstonmethodist.org   
Sponsors and Collaborators
BrainScope Company, Inc.
United States Department of Defense
Investigators
Principal Investigator: Kenneth Podell, Ph.D., FACPN The Neurological Institute, Houston Methodist
  More Information

Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT02957461     History of Changes
Other Study ID Numbers: 18-Ahead 
Study First Received: November 3, 2016
Last Updated: November 4, 2016

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on January 19, 2017