The Effects of Head Trauma on Collegiate Athletes

Sponsor

Boston Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02354469

Collaborator

Harvard University (Other), Beth Israel Deaconess Medical Center (Other), Brigham and Women's Hospital (Other), Spaulding Rehabilitation Hospital (Other)

300

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Aug 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Dynamic Balance Control [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

Cognitive Function [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.
EEG signals [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.
Blood and Urine samples [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
Neuroimaging [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participation on a Harvard University varsity athletic team
Medically cleared to participate in sport, as determined by Harvard medical staff
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)
No diagnosed concussion within the previous year of evaluation (control group)

Exclusion Criteria:

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.
Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy.
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.
Any unstable medical condition
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.