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Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization (AheadCAS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2015 by BrainScope Company, Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
BrainScope Company, Inc.
ClinicalTrials.gov Identifier:
NCT02477943
First received: June 15, 2015
Last updated: June 18, 2015
Last verified: June 2015
  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

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: 450
Study Start Date: August 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: March 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 tim eof 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 collegiate athletes.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 450 male and female student-athletes from participating universities or colleges 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. Evidence of illicit drug usage
  2. Do not speak or read English
  3. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
  4. Skull abnormalities, e.g. metal plate
  5. history of brain surgery or neurological disease.
  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: NCT02477943

Contacts
Contact: Douglas C Oberly 2407527680 ext 1015 doug.oberly@brainscope.com
Contact: Diane Pizzano 2407527680 ext 1023 diane.pizzano@brainscope.com

Sponsors and Collaborators
BrainScope Company, Inc.
Investigators
Principal Investigator: Kenneth Podell, Ph.D., FACPN The Neurological Institute, Houston Methodist
  More Information

No publications provided

Responsible Party: BrainScope Company, Inc.
ClinicalTrials.gov Identifier: NCT02477943     History of Changes
Other Study ID Numbers: 14-Ahead
Study First Received: June 15, 2015
Last Updated: June 18, 2015
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 July 01, 2015