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Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in High School Athletes (AheadCAS - HS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by BrainScope Company, Inc.
Sponsor:
Information provided by (Responsible Party):
BrainScope Company, Inc.
ClinicalTrials.gov Identifier:
NCT02661633
First received: January 19, 2016
Last updated: NA
Last verified: January 2016
History: No changes posted
  Purpose
This study is designed to collect data which will be used to correlate changes in EEG to mild TBI in sports concussion.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in High School Athletes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Collect electrophysiological and clinical data which will be used to correlate changes in EEG to mild TBI in sports concussion. [ Time Frame: Participants will be followed an expected average of 55 days ] [ Designated as safety issue: No ]
    Create a database of brain electrical activity (EEG) and clinical information collected from athletes who sustain a concussion during organized sports.


Estimated Enrollment: 150
Study Start Date: January 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Population Pool
The Population Pool will consist of contact and non-contact athletes recruited at each site participating in the study. The athlete's in this pool will be tested with the study device pre-season and post-season each. The BrainScope Battery consists of 3 components to collect brain electrical activity, a cognitive assessment and a balance/sway measurement.
Device: BrainScope Battery
The BrainScope Battery consists of 3 components to collect brain electrical activity, a cognitive assessment and a balance/sway measurement.
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 3 follow-up time points. The BrainScope Battery consists of 3 components to collect brain electrical activity, a cognitive assessment and a balance/sway measurement. In addition, the injured and matched control athletes will receive advanced MRI neuroimaging.
Device: BrainScope Battery
The BrainScope Battery consists of 3 components to collect brain electrical activity, a cognitive assessment and a balance/sway measurement.
Device: 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.
Other Names:
  • Magnetic Resonance Imaging
  • Diffusion Tension Imaging

Detailed Description:

The study will include obtaining baseline measurements before the season begins in a subset of athletes. 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. A pool of contact and non-contact athletes will obtain a baseline measurement prior to the season and then after the season has ended.

The study is designed to populate a large database of electrophysiological and clinical data from high school athletes.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 150 male and female student-athletes from participating high schools will be invited to participate.
Criteria

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.

Exclusion Criteria:

  1. Do not speak or read English
  2. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
  3. Skull abnormalities, e.g. metal plate
  4. History of brain surgery or neurological disease
  5. Pregnant women.
  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: NCT02661633

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, Michigan
Michigan State University Recruiting
East Lansing, Michigan, United States, 48824
Contact: Tracey Covassin, PhD    517-353-2010    covassin@ath.msu.edu   
Contact: Erika Beidler    814-449-7438    beidlere@msu.edu   
United States, Texas
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
BrainScope Company, Inc.
Investigators
Study Director: Douglas C Oberly BrainScope Company, Inc.
  More Information

No publications provided

Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT02661633     History of Changes
Other Study ID Numbers: 16-Ahead 
Study First Received: January 19, 2016
Last Updated: January 19, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 07, 2016