The Effects of Head Trauma on Collegiate Athletes
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 25 |
| Updated: | 10/7/2017 |
| Start Date: | August 2015 |
| End Date: | August 2020 |
| Contact: | David R Howell, PhD |
| Email: | David.Howell2@childrens.harvard.edu |
| Phone: | 781-216-2865 |
The Effects of Head Trauma on Biological Markers and Neurologic Function in Collegiate Athletes: a Prospective Investigation
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.
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.
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.
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.
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.
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Phone: 781-216-2865
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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