Brain ConcussionNCT02519998
Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
An observational study of Brain Concussion, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Concussion
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2016
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals ages 10 or older. If the patient has experienced a suspected concussion, must be a patient at the Jefferson Comprehensive Concussion Center.
Who may be able to join
- All patients, 10 years of age or older with concussion being evaluated at the Jefferson Comprehensive Concussion Center in Philadelphia, PA, or by Jefferson Comprehensive Concussion Center physicians at other locations (including Rothman Institute sports medicine clinics in Bryn Mawr, PA, Marlton, NJ, Washington Township, NJ). The target population will be those with suspected concussions.
Who cannot join
- Patients not presenting at the Jefferson Comprehensive Concussion Center or affiliated locations.
Trial locations and contacts
1 site in 1 country.
Mijail Serruya, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Jefferson Comprehensive Concussion Center
Philadelphia, Pennsylvania, 19112
Mijail Serruya, MD, PhD, 267-463-2300
About this study
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.
Read the detailed description
Concussions comprise a type of mild traumatic brain injury in which mechanical forces disrupt brain metabolism causing transient neurological symptoms.
At the current time, there is no universally agreed-upon objective biomarker or risk calculator of concussion upon which physicians can prognosticate future risk, identify optimal treatments, and for sports medicine physicians, decide if and when a particular player were safe to be returned to play.
While the majority of patients experience a full recovery within a few weeks of a concussion, several going on to have chronic, debilitating symptoms, and all patients experience a permanently increased risk of experiencing more debilitating and long-lasting symptoms with each subsequent concussion. For certain people with certain genetic (e.g., ApoE status) and psychosocial (e.g., alcohol abuse, depression) risk factors, even a single concussion can put them at greater risk for earlier and more severe forms of dementia decades hence.
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.
This study plans to collect biological specimens (blood, saliva, urine, hair follicles), electrophysiological (EEG, EKG), imaging (HCT, MRI, PET, SPECT), ambulatory (actigraphy), sensory thresholds (Von Frey), ophthalmologic (fundoscopic photographs, OCT, SSVEPs), vestibular (ENG, BESS, BioSway) along with demographic, medical history, medication, psychosocial data and the results on validated instruments of cognition, mood, sleep, head discomfort and quality of life.
Because it is important to determine the variability not only within the concussion group but also between groups, the investigators will also recruit a control cohort, specifically athletes who are already undergoing baseline cognitive testing pre-season. The clinical focus of this study will be on concussed athletes, both children and adults, and the investigators will also include non-sports patients who have mild traumatic brain injury due to other situations including slip and fall, occupational, motor vehicle accidents, assault, and blast exposure.
- Conditions
- Brain Concussion
- Being tested
- Concussion
- Keywords
- Biomarkers, Electrocardiography, Balance, Neuropsychiatric assessment, Cortisol, Calcitonin-gene-related peptide, Electroencephalography, Optical coherence tomography, Von Frey Testing
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcussionOther
Study groups are differentiated based on presence of concussion. No intervention is being made in either population (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Concussed patients | The clinical focus of this study will be on concussed athletes, both children and adults, and we will also include non-sports patients who have mild traumatic brain injury due to other situations including slip and fall, occupational, motor vehicle accidents, assault, and blast exposure. Receives: Other: Concussion | |
| Non-concussed patients | Cohort control. Primarily athletes who undergo routine pre-season baseline assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical history indicative of concussion
Basic medical history demographics gathered during patient's regular clincal visit.
Measured: Upon enrollment
Secondary outcomes (34)
Neurocognitive Testing and Assessment Batteries
Sports Concussion Assessment Tool (SCAT-3)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Balance Error Scoring System (BESS)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
King Devick Test
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Acute Concussion Evaluation (ACE)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Beck Depression Inventory (BDI)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Beck Anxiety Inventory (BAI)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
World Health Organization-Five Well-being Index (WHO-5)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Multidimensional Anxiety Scale for Children (MASC)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Spence Children's Anxiety Scale
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
"SCARED" Montgomery-Åsberg Depression Rating Scale
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
ImPACT
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Trails A and B Forward
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Reverse Digit Span
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Jefferson After Concussion Test (JACT)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Rivermead Post Concussion Symptom Questionnaire (RPQ)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Traumatic Brain Injury-Quality of Life (TBI-QOL)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Mayo-Portland Adaptability Inventory (MPAI-4)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Migraine Disability Assessment (MIDAS)
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Fatigue Severity Scale
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Epworth Sleepiness Scale
Measured: 1 year
Neurocognitive Testing and Assessment Batteries
Pittsburgh Sleep Quality Index
Measured: 1 year
Diagnostic Procedures
Galvanic skin response
Measured: 1 year
Diagnostic Procedures
Electrocardiography (EKG)
Measured: 1 year
Diagnostic Procedures
Electroencephalography (EEG)
Measured: 1 year
Diagnostic Procedures
Fundoscopy Optical Coherence Tomography (OCT)
Measured: 1 year
Diagnostic Procedures
Von Frey Sensory Filament Thresholds
Measured: 1 year
Diagnostic Procedures
BioSway
Measured: 1 year
Biospecimens
Blood
Measured: 1 year
Biospecimens
Siliva
Measured: 1 year
Biospecimens
Urine
Measured: 1 year
Clinically Acquired Imaging
CT, MRI
Measured: 1 year
Opthalmologic
Fundoscopic photographs
Measured: 1 year
Opthalmologic
Optical coherence tomography
Measured: 1 year
Tactile Sensation
Von Frey sensory thresholds
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 posted11 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Rothman Institute Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Mijail Serruya, MD, PhD, Principal investigator, TJUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519998
- Sponsor's protocol ID
- 14D.611
- Status last verified
- Aug 2015
- First submitted
- 25 Mar 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Repository and Master Database for Concussion Biomarker and Risk Calculator Development
- ClinicalTrials.gov ID
- NCT02519998
- Acronym / sponsor ID
- 14D.611
- Conditions
- Brain Concussion
- Keywords
- Biomarkers, Electrocardiography, Balance, Neuropsychiatric assessment, Cortisol, Calcitonin-gene-related peptide, Electroencephalography, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Rothman Institute Orthopaedics
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Aug 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.
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.
Detailed description
Concussions comprise a type of mild traumatic brain injury in which mechanical forces disrupt brain metabolism causing transient neurological symptoms.
At the current time, there is no universally agreed-upon objective biomarker or risk calculator of concussion upon which physicians can prognosticate future risk, identify optimal treatments, and for sports medicine physicians, decide if and when a particular player were safe to be returned to play.
While the majority of patients experience a full recovery within a few weeks of a concussion, several going on to have chronic, debilitating symptoms, and all patients experience a permanently increased risk of experiencing more debilitating and long-lasting symptoms with each subsequent concussion. For certain people with certain genetic (e.g., ApoE status) and psychosocial (e.g., alcohol abuse, depression) risk factors, even a single concussion can put them at greater risk for earlier and more severe forms of dementia decades hence.
The purpose of this study is to prospectively collect a comprehensive, multi-modality set of diagnostics on patients who have had a concussion, repeating some of these tests serially over time, so that the investigators may then in the future perform retrospective data mining to determine if there were a biomarker or risk calculator that could be used to guide return-to-play and other medical decisions.
This study plans to collect biological specimens (blood, saliva, urine, hair follicles), electrophysiological (EEG, EKG), imaging (HCT, MRI, PET, SPECT), ambulatory (actigraphy), sensory thresholds (Von Frey), ophthalmologic (fundoscopic photographs, OCT, SSVEPs), vestibular (ENG, BESS, BioSway) along with demographic, medical history, medication, psychosocial data and the results on validated instruments of cognition, mood, sleep, head discomfort and quality of life.
Because it is important to determine the variability not only within the concussion group but also between groups, the investigators will also recruit a control cohort, specifically athletes who are already undergoing baseline cognitive testing pre-season. The clinical focus of this study will be on concussed athletes, both children and adults, and the investigators will also include non-sports patients who have mild traumatic brain injury due to other situations including slip and fall, occupational, motor vehicle accidents, assault, and blast exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed patients | – | Other: ConcussionThe clinical focus of this study will be on concussed athletes, both children and adults, and we will also include non-sports patients who have mild traumatic brain injury due to other situations including slip and fall, occupational, motor vehicle accidents, assault, and blast exposure. |
| Non-concussed patients | – | –Cohort control. Primarily athletes who undergo routine pre-season baseline assessment |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals ages 10 or older. If the patient has experienced a suspected concussion, must be a patient at the Jefferson Comprehensive Concussion Center.
Key inclusion criteria (1 listed)
- All patients, 10 years of age or older with concussion being evaluated at the Jefferson Comprehensive Concussion Center in Philadelphia, PA, or by Jefferson Comprehensive Concussion Center physicians at other locations (including Rothman Institute sports medicine clinics in Bryn Mawr, PA, Marlton, NJ, Washington Township, NJ). The target population will be those with suspected concussions.
Key exclusion criteria (1 listed)
- Patients not presenting at the Jefferson Comprehensive Concussion Center or affiliated locations.
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 |
|---|---|---|
| ConcussionStudy groups are differentiated based on presence of concussion. No intervention is being made in either population (observational study) | Other | Concussed patients |
Primary outcome
Medical history indicative of concussion
Time frame: Upon enrollment
Basic medical history demographics gathered during patient's regular clincal visit.
34 secondary outcomes
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Neurocognitive Testing and Assessment Batteries
Time frame: 1 year
Diagnostic Procedures
Time frame: 1 year
Diagnostic Procedures
Time frame: 1 year
Diagnostic Procedures
Time frame: 1 year
Diagnostic Procedures
Time frame: 1 year
Diagnostic Procedures
Time frame: 1 year
Diagnostic Procedures
Time frame: 1 year
Biospecimens
Time frame: 1 year
Biospecimens
Time frame: 1 year
Biospecimens
Time frame: 1 year
Clinically Acquired Imaging
Time frame: 1 year
Opthalmologic
Time frame: 1 year
Opthalmologic
Time frame: 1 year
Tactile Sensation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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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.
Mijail Serruya, MD, PhD contact
Mijail Serruya, MD, PhD principal investigator
TJUH
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 Brain Concussion, run by Thomas Jefferson University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mijail Serruya, MD, PhD (267-463-2300), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical history indicative of concussion (time frame: Upon enrollment). 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 11 Aug 2015.