The Effects of Head Trauma on Collegiate Athletes

NCT02354469 | Completed

• 1 other identifier: IRB-P00016469
• Study Type: observational
• Target: 437
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Concussion; Brain Injuries

Keywords

TBI; Mild Traumatic Brain Injury; Post-Concussion Syndrome; Recovery of Function; Motor Activity; Diffusion Tensor Imaging; Neural Injury; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cognitive Function

  1 year

• EEG signals

  1 year

• Blood and Urine samples

  1 year

• Neuroimaging

  1 year

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be comprised of active members of various varsity teams at Harvard University.

You may qualify if:

• 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)

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Harvard University: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• 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.

  PMID: 28895490 BACKGROUND

• 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.

  PMID: 28919121 BACKGROUND

• 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.

  PMID: 27705076 BACKGROUND

• 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.

  PMID: 31141425 BACKGROUND

• 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.

  PMID: 29490564 BACKGROUND

• Daisy CC, Varinos S, Howell DR, Kaplan K, Mannix R, Meehan WP, Wang F, Berkstresser B, Lee RS, Froehlich JW, Zurakowski D, Moses MA. Proteomic Discovery of Noninvasive Biomarkers Associated With Sport-Related Concussions. Neurology. 2022 Jan 11;98(2):e186-e198. doi: 10.1212/WNL.0000000000013001. Epub 2021 Oct 21.

  PMID: 34675105 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood samples will be acquired and stored in a biorepository.

MeSH Terms

Conditions

Brain Concussion; Brain Injuries; Post-Concussion Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Study Officials

• William P Meehan III, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: August 1, 2015
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)