Traumatic Brain InjuryGATORNCT01472042
A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
An observational study of Traumatic Brain Injury and Sports Concussion, run by Banyan Biomarkers, Inc at 1 site in United States.
Trial summary
The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college sports. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Sports Concussion, Sports Injury
- What is being tested?
- Banyan Biomarkers
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll athletes at the University of Florida, Gainesville. Teams considered for inclusion in the study are men's football, women's lacrosse and women's soccer.
Who may be able to join
- The subject is a University of Florida student athlete on a team participating in the study
- The Subject is at least 18 years of age at screening (has had their 18th birthday)
- The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
- It is the Principal Investigator's opinion that based on the knowledge of the Subject that the Subject is an appropriate candidate for the study.
Who cannot join
- Participating in another clinical study that may affect the results of either study.
- Venipuncture not feasible (i.e. skin integrity compromised at the venipuncture sites, blood vessel calcification.
- Not available for the end of season follow-up visit.
- The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college sports.
Read the detailed description
Concussion or mild traumatic brain injury (mTBI) is a condition that affects hundreds of thousands of patients worldwide. It is a biomechanically induced neurological injury, resulting in an alteration of mental status, such as confusion or amnesia, which may or may not involve a loss of consciousness. Concussion affects about 1.6 million to 3.8 million athletes yearly, most commonly in contact sports such as American football and boxing. Early clinical effects of concussion include but are not limited to behavioral changes, impairments of memory and attention, headache, unsteadiness, and rarely, catastrophic severe brain injury (sometimes described as second impact syndrome). More recently, the consequences of repetitive mTBI from multiple concussions in a sports setting are becoming evident. Repeated concussions have been associated with greater severity of symptoms, with longer recovery time, and chronically with earlier onset of age-related memory disturbances and dementia. As a result and in contradistinction to the decades-earlier perception that these injuries were benign, sports medicine professionals are now increasingly being instructed to recognize and manage concussions as soon as they occur. "Understanding the neurobiology of concussion will lead to development and validation of physiological biomarkers of this common injury." These biomarkers (e.g., laboratory tests, imaging, electrophysiology) will then allow for improved detection, better functional assessment and evidence-based return to play recommendations.
- Conditions
- Traumatic Brain Injury, Sports Concussion, Sports Injury
- Being tested
- Banyan Biomarkers
- Keywords
- Traumatic Brain Injury, Sport Concussion, Head Injury, Sports Injury
- Medical subject headings
- Brain Injuries, Traumatic, Athletic Injuries, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banyan BiomarkersOther
Biomarkers to detect specific proteins.
| Study group | Role | What they receive |
|---|---|---|
| Sports induced concussion | Exposure to sports induced concussion Receives: Other: Banyan Biomarkers | |
| Routine Athletic Exertion | Exposure to routine athletic exertion (non-concussion control) Receives: Other: Banyan Biomarkers | |
| Other Non-Penetrating Trauma to the Head | Exposure to other non-penetrating trauma to the head that is witnessed or self-reported Receives: Other: Banyan Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of TBI biomarkers from baseline
Measured: 36 months
Secondary outcomes (5)
Association of TBI biomarker levels and the Post-Concussion Scale
Measured: 36 months
Association of TBI biomarker levels and the Standardized Assessment of Concussion
Measured: Baseline (beginning of Sports season), Active Phase (during Sports Season) and End of Sports Season
Association of TBI biomarker levels and the Balance Error Scoring System
Measured: 36 months
Safety
The safety endpoints include the cumulative procedure-related adverse event-free survival, and cumulative unanticipated procedure-related adverse events. The only potential risks to patients in this study are those that are normally related to routine blood collection.
Measured: Throughout Participation in Study
Assessment of pituitary status and determination of the presence of autoantibodies.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banyan Biomarkers, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Clugston, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472042
- Sponsor's protocol ID
- ATO-07
- Acronym
- GATOR
- Status last verified
- Jul 2016
- First submitted
- 7 Sep 2011
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
- ClinicalTrials.gov ID
- NCT01472042
- Acronym / sponsor ID
- GATOR / ATO-07
- Conditions
- Traumatic Brain Injury, Sports Concussion, Sports Injury
- Keywords
- Traumatic Brain Injury, Sport Concussion, Head Injury, Sports Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Nov 2011 (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.
The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college sports.
Detailed description
Concussion or mild traumatic brain injury (mTBI) is a condition that affects hundreds of thousands of patients worldwide. It is a biomechanically induced neurological injury, resulting in an alteration of mental status, such as confusion or amnesia, which may or may not involve a loss of consciousness. Concussion affects about 1.6 million to 3.8 million athletes yearly, most commonly in contact sports such as American football and boxing. Early clinical effects of concussion include but are not limited to behavioral changes, impairments of memory and attention, headache, unsteadiness, and rarely, catastrophic severe brain injury (sometimes described as second impact syndrome). More recently, the consequences of repetitive mTBI from multiple concussions in a sports setting are becoming evident. Repeated concussions have been associated with greater severity of symptoms, with longer recovery time, and chronically with earlier onset of age-related memory disturbances and dementia. As a result and in contradistinction to the decades-earlier perception that these injuries were benign, sports medicine professionals are now increasingly being instructed to recognize and manage concussions as soon as they occur. "Understanding the neurobiology of concussion will lead to development and validation of physiological biomarkers of this common injury." These biomarkers (e.g., laboratory tests, imaging, electrophysiology) will then allow for improved detection, better functional assessment and evidence-based return to play recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sports induced concussion | – | Other: Banyan BiomarkersExposure to sports induced concussion |
| Routine Athletic Exertion | – | Other: Banyan BiomarkersExposure to routine athletic exertion (non-concussion control) |
| Other Non-Penetrating Trauma to the Head | – | Other: Banyan BiomarkersExposure to other non-penetrating trauma to the head that is witnessed or self-reported |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll athletes at the University of Florida, Gainesville. Teams considered for inclusion in the study are men's football, women's lacrosse and women's soccer.
Key inclusion criteria (4 listed)
- The subject is a University of Florida student athlete on a team participating in the study
- The Subject is at least 18 years of age at screening (has had their 18th birthday)
- The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
- It is the Principal Investigator's opinion that based on the knowledge of the Subject that the Subject is an appropriate candidate for the study.
Key exclusion criteria (4 listed)
- Participating in another clinical study that may affect the results of either study.
- Venipuncture not feasible (i.e. skin integrity compromised at the venipuncture sites, blood vessel calcification.
- Not available for the end of season follow-up visit.
- The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Banyan BiomarkersBiomarkers to detect specific proteins. | Other | Other Non-Penetrating Trauma to the Head, Routine Athletic Exertion, Sports induced concussion |
Primary outcome
Change in levels of TBI biomarkers from baseline
Time frame: 36 months
5 secondary outcomes
Association of TBI biomarker levels and the Post-Concussion Scale
Time frame: 36 months
Association of TBI biomarker levels and the Standardized Assessment of Concussion
Time frame: Baseline (beginning of Sports season), Active Phase (during Sports Season) and End of Sports Season
Association of TBI biomarker levels and the Balance Error Scoring System
Time frame: 36 months
Safety
Time frame: Throughout Participation in Study
Assessment of pituitary status and determination of the presence of autoantibodies.
Time frame: 36 months
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 20 Jul 2016.
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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.
Jay Clugston, MD principal investigator
University of Florida
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 Traumatic Brain Injury and Sports Concussion, run by Banyan Biomarkers, Inc 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 4 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 20 Jul 2016. 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?
Change in levels of TBI biomarkers from baseline (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2016.