Mild Traumatic Brain InjuryNCT01673464
A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion
An observational study of Mild Traumatic Brain Injury, run by ElMindA Ltd at 1 site in United States.
Trial summary
The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2014
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: High school (13-18 yrs) athletes from American football, soccer, and lacrosse who meet the inclusion/exclusion criteria will be recruited into the study. We expect that between 10-20 participants will sustain a concussion during the period of the study and complete the post-concussion protocol.
Who may be able to join
- Aged 13-18 years
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
Who cannot join
- Current or history of TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression, bipolar disorder, schizophrenic disorder
- Substance abuse within the last year
- Current or history of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder
- Current or history of any Neurological disorder, e.g., epilepsy, seizures
- History of any medication affecting CNS within the last year, e.g., antidepressants, anticonvulsants, Ritalin, first generation antihistamines, etc.
Show all 13Show fewer
- Current or history of Significant sensory deficits such as deafness or blindness
- Current or history of Clinically significant abnormal laboratory values or ECG
- A concussion within the last year
- Current or history of residual symptoms or deficits related to a previous concussion
- Diagnosis of autistic spectrum disorders, e.g., Asperger's syndrome, High functioning Autism, PDD
- Currently with lice or open wounds on scalp
- Long and thick hair that prevents the proper administration of an EEG cap
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Sports Medicine Concussion Program
Pittsburgh, Pennsylvania, 15203
About this study
The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mild Traumatic Brain Injury, mTBI, Concussion
- Medical subject headings
- Brain Concussion
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 |
|---|---|---|
| High School Athletes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period
To examine prospectively changes in brain network activation (BNA) from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.
Measured: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Secondary outcomes (3)
Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period
To investigate the relationship between changes in BNA to changes in symptoms from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.
Measured: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period
To investigate the relationship between changes in BNA to changes in cognitive performance from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.
Measured: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period
To investigate the relationship between changes in BNA to changes in vestibular function from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.
Measured: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673464
- Sponsor's protocol ID
- ELM-12
- Status last verified
- Apr 2015
- First submitted
- 21 Aug 2012
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion
- ClinicalTrials.gov ID
- NCT01673464
- Acronym / sponsor ID
- ELM-12
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mild Traumatic Brain Injury, mTBI, Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Aug 2012 (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 main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes. In addition, the study will examine the relationship between changes in BNA to symptoms, cognitive performance and vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high school athletes with concussion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High School Athletes | – | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- High school (13-18 yrs) athletes from American football, soccer, and lacrosse who meet the inclusion/exclusion criteria will be recruited into the study. We expect that between 10-20 participants will sustain a concussion during the period of the study and complete the post-concussion protocol.
Key inclusion criteria (3 listed)
- Aged 13-18 years
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
Key exclusion criteria (13 listed)
- Current or history of TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- Current or history of any psychiatric disorder (except ADD/ADHD), e.g., depression, bipolar disorder, schizophrenic disorder
- Substance abuse within the last year
- Current or history of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder
- Current or history of any Neurological disorder, e.g., epilepsy, seizures
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
Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period
Time frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
To examine prospectively changes in brain network activation (BNA) from baseline to 1-7, 8-14, and 15-21 day post-injury intervals, and/or to recovery (i.e., return to activity) in high school athletes with concussion.
3 secondary outcomes
Relationship between changes in BNA to changes in symptoms from baseline over post concussion recovery period
Time frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Relationship between changes in BNA to changes in cognitive performance from baseline over post concussion recovery period
Time frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
Relationship between changes in BNA to changes in vestibular function from baseline over post concussion recovery period
Time frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals
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 9 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mild Traumatic Brain Injury, run by ElMindA Ltd 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 3 inclusion and 13 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 9 Apr 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?
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?
Changes in Brain Network Activation(BNA™)Scores From Baseline Over Post Concussion Recovery Period (time frame: baseline, 1-7, 8-14, and 15-21 day post-injury intervals). 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 9 Apr 2015.