Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Head Trauma on Collegiate Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02354469
Recruitment Status : Recruiting
First Posted : February 3, 2015
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
Harvard University
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
David R Howell, University of Colorado, Denver

Brief Summary:
Recently, researchers and clinicians have examined many different forms of concussion testing aimed to assess if a brain injury has occurred and to what degree it affects the individual being tested. Due to the multifaceted and complex presentation of concussive injuries and the unknown effects of repeated head trauma, it is unlikely that a single test of physiological or behavioral function will reflect the full range of injury-related damages from a concussive event or from a series of cumulative head traumas, as well as the injury response within brain tissue. However, by combining a variety of objective assessments which may detect structural and functional alterations following head trauma into a single study, a clearer understanding of the multi-faceted presentation resulting from head trauma may be identified. The identification of biomarkers and the utilization of objective and clinically feasible tools will provide a method to assess three domains across multiple systems affected by head trauma: 1) the prognostic value of initial concussion assessments to identify injury severity and factors responsible for prolonged recovery, 2) the temporal window of recovery and potential vulnerability of brain tissue post-injury, and 3) the long-term alterations associated with repeated head trauma exposure.

Condition or disease
Cerebral Concussion Brain Injuries

Detailed Description:

Student athletes from contact and collision sports, as well as non-contact sports, will complete a comprehensive assessment of neurological and behavioral function before and after a season of participation. Additionally, those who sustain a concussion will undergo a post-injury testing timeline where they are assessed within 5 days of injury and again at the following time points: 3-4 weeks, 3 months, 6 months, and 1 year post-injury. Each individual who completes testing as a concussion subject will be matched with a healthy control subject by height, weight, age, sport, and position, and each control subject will complete the same protocol in similar time increments as subjects with concussion.

Through this study design, we hypothesize that we will be able to detect objective deficits resulting from concussion within one week of injury and determine the feasibility and added value of a comprehensive neurological and behavioral testing battery through a comparison of metrics between injured and healthy collegiate student athletes. Additionally, we hypothesize that for athletes who do not sustain a concussion, decrements between the pre-season and post-season time points will be greater in those who participate in collision/contact sports in comparison to those who participate in non-contact sports. Thus, outcomes from this study will enhance the understanding of the pathophysiology of concussion through a rigorous laboratory testing component, but with simultaneous direct translation to clinical implementation through the use of a highly-feasible clinical testing paradigm that possesses potential for ubiquitous and widespread use throughout sports medicine practices.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Head Trauma on Biological Markers and Neurologic Function in Collegiate Athletes: a Prospective Investigation
Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Contact/Collision Sport Athletes
Collegiate athletes who participate in contact or collision sports will be assessed on a comprehensive battery of tests during pre-season and post-season assessments.
Non-contact Sport Athletes
Collegiate athletes who participate in non-contact sports will be assessed on a comprehensive battery of tests during pre-season and post-season assessments.
Post-Concussion
Collegiate athletes who sustain a concussion will be assessed on a comprehensive battery of tests from the time of injury and incrementally throughout the following year post-injury.
Healthy Control
Collegiate athletes who do not sustain a concussion but match the demographic profile of an individual enrolled as a post-concussion subject, will be assessed on the same tests and in a similar timeline as post-concussion subjects.



Primary Outcome Measures :
  1. Dynamic Balance Control [ Time Frame: 1 year ]
    For balance control measures, the primary data will come from accelerometers placed on specific anatomical landmarks to assess whole body movement. Peak accelerations and velocities of an estimated center-of-mass during gait under single-task and dual-task conditions will identify how divided attention tasks affect whole body balance control.


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: 1 year ]
    Concussion-Rapid Assessment Module, simple and choice reaction times, Trail Making Tests A and B, Balance Error Scoring System, and static and dynamic visual acuity will be assessed.

  2. EEG signals [ Time Frame: 1 year ]
    We plan to examine a variety of conventional EEG measures including resting-state power and functional connectivity, as well as task-related evoked potentials, functional connectivity changes, and event-related spectral perturbation.

  3. Blood and Urine samples [ Time Frame: 1 year ]
    We will primarily investigate previously documented markers of neuronal integrity GFAP, UCH-L1, and SB100 (blood) and levels of protein concentration in urine

  4. Neuroimaging [ Time Frame: 1 year ]
    Primary measures will include: gross and regional volumes of brain structures, water molecule diffusion (axial diffusivity, fractional anisotropy, radial diffusivity, and mean diffusivity), and neurochemical imaging (levels of NAA, Cr, Cho, Glu, GSH, and MI).


Biospecimen Retention:   Samples Without DNA
Urine and blood samples will be acquired and stored in a biorepository.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be comprised of active members of various varsity teams at Harvard University.
Criteria

Inclusion Criteria:

  1. Participation on a Harvard University varsity athletic team
  2. Medically cleared to participate in sport, as determined by Harvard medical staff
  3. Diagnosed with concussion by Harvard medical staff, and agreement to participate in the post-injury component of the study within five days of injury (post-concussion group)
  4. No diagnosed concussion within the previous year of evaluation (control group)

Exclusion Criteria:

  1. A history of epilepsy, prior seizure, or any previous abnormal EEG finding or abnormal brain imaging (CT or MRI) finding, as reported by the patient.
  2. Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy.
  3. Any currently active psychiatric condition, including specifically major depression, bipolar disorder or schizophrenia. A history of a psychiatric condition but no ongoing psychiatric episode (e.g. not currently undergoing treatment for a major depressive episode) would not be an exclusion.
  4. Any unstable medical condition
  5. For the transcranial Doppler ultrasound component of the study only, subjects with infection, history of seizure, cardioactive drug participation, presence of deep vein thrombosis, cervical injury (structural or vascular), gross motor deficits, or skull fractures will be excluded.

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): NCT02354469


Contacts
Layout table for location contacts
Contact: David R Howell, PhD 781-216-2865 David.Howell2@childrens.harvard.edu
Contact: Anna Brilliant, BS 781-216-3085 Anna.Brilliant@childrens.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: David Howell    781-216-2865    David.Howell2@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Harvard University
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Spaulding Rehabilitation Hospital
Investigators
Layout table for investigator information
Principal Investigator: William P Meehan III, MD Boston Children’s Hospital

Publications:
Layout table for additonal information
Responsible Party: David R Howell, Assistant Professor, University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02354469     History of Changes
Other Study ID Numbers: IRB-P00016469
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David R Howell, University of Colorado, Denver:
TBI
Mild Traumatic Brain Injury
Post-Concussion Syndrome
Recovery of Function
Motor Activity
Diffusion Tensor Imaging
Neural Injury
Biomarkers

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Craniocerebral Trauma
Brain Concussion
Brain Diseases
Trauma, Nervous System
Wounds and Injuries
Brain Injuries, Traumatic
Head Injuries, Closed
Wounds, Nonpenetrating
Central Nervous System Diseases
Nervous System Diseases