Cerebral ConcussionNCT02354469
The Effects of Head Trauma on Collegiate Athletes
An observational study of Cerebral Concussion and Brain Injuries, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Concussion, Brain Injuries
- How many people
- 437 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be comprised of active members of various varsity teams at Harvard University.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Brain Concussion, Brain Injuries, Post-Concussion Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startAug 2015
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral ConcussionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, David R Howell, University of Colorado, Denver
- Investigators
- William P Meehan III, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354469
- Sponsor's protocol ID
- IRB-P00016469
- Status last verified
- Oct 2023
- First submitted
- 29 Jan 2015
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28895490Howell 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.
PubMed 28919121Howell 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.
PubMed 27705076Howell 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.
PubMed 31141425Howell 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.
PubMed 29490564Daisy 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.
PubMed 34675105
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Head Trauma on Biological Markers and Neurologic Function in Collegiate Athletes: a Prospective Investigation
- ClinicalTrials.gov ID
- NCT02354469
- Acronym / sponsor ID
- IRB-P00016469
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Harvard University, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
- Study start
- Aug 2015
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be comprised of active members of various varsity teams at Harvard University.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Cognitive Function
Time frame: 1 year
EEG signals
Time frame: 1 year
Blood and Urine samples
Time frame: 1 year
Neuroimaging
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Background: PubMed 28895490Howell 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.
- Background: PubMed 28919121Howell 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.
- Background: PubMed 27705076Howell 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.
- Background: PubMed 31141425Howell 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.
- Background: PubMed 29490564Howell 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.
- Derived from this study: PubMed 34675105Daisy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William P Meehan III, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Concussion and Brain Injuries, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Balance Control (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354469, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.