The Effects of Head Trauma on Collegiate Athletes

Brain Injuries Clinical Trial

Official title:

The Effects of Head Trauma on Biological Markers and Neurologic Function in Collegiate Athletes: a Prospective Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354469
• Other study ID #: IRB-P00016469
• Status: Completed
• Start date: August 2015
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Cerebral Concussion
• Craniocerebral Trauma

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Boston Children's Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Harvard University, Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Howell DR, Brilliant A, Berkstresser B, Wang F, Fraser J, Meehan WP 3rd. The Association between Dual-Task Gait after Concussion and Prolonged Symptom Duration. J Neurotrauma. 2017 Dec 1;34(23):3288-3294. doi: 10.1089/neu.2017.5191. Epub 2017 Oct 16. — View Citation

Howell DR, Buckley TA, Berkstresser B, Wang F, Meehan WP 3rd. Identification of Post-Concussion Dual-Task Gait Abnormalities Using Normative Reference Values. J Appl Biomech. 2019 Aug 1;35(4):290-296. doi: 10.1123/jab.2018-0454. Epub 2019 May 29. — View Citation

Howell DR, Buckley TA, Lynall RC, Meehan WP 3rd. Worsening Dual-Task Gait Costs after Concussion and their Association with Subsequent Sport-Related Injury. J Neurotrauma. 2018 Jul 15;35(14):1630-1636. doi: 10.1089/neu.2017.5570. Epub 2018 May 3. — View Citation

Howell DR, Oldham JR, DiFabio M, Vallabhajosula S, Hall EE, Ketcham CJ, Meehan WP 3rd, Buckley TA. Single-Task and Dual-Task Gait Among Collegiate Athletes of Different Sport Classifications: Implications for Concussion Management. J Appl Biomech. 2017 Feb;33(1):24-31. doi: 10.1123/jab.2015-0323. Epub 2016 Oct 5. — View Citation

Howell DR, Stillman A, Buckley TA, Berkstresser B, Wang F, Meehan WP 3rd. The utility of instrumented dual-task gait and tablet-based neurocognitive measurements after concussion. J Sci Med Sport. 2018 Apr;21(4):358-362. doi: 10.1016/j.jsams.2017.08.004. Epub 2017 Aug 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Balance Control	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.	1 year
Secondary	Cognitive Function	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.	1 year
Secondary	EEG signals	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.	1 year
Secondary	Blood and Urine samples	We will primarily investigate previously documented markers of neuronal integrity GFAP, UCH-L1, and SB100 (blood) and levels of protein concentration in urine	1 year
Secondary	Neuroimaging	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).	1 year