Minor Traumatic Brain Injury (TBI)NCT01923441
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.
An observational study of Minor Traumatic Brain Injury (TBI), run by ElMindA Ltd at 1 site in United States.
Trial summary
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to… Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Minor Traumatic Brain Injury (TBI)
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Up to 300 athletes from Nazareth Academy, Deerfield High School and the Deerfield young warriors program athletes, from both genders, aged 10-19 years
Who may be able to join
- Athletes Ages 10-19, both genders, enrolled in Nazareth Academy , Deerfield High School or the Deerfield young warriors youth Football program .
Who cannot join
- Self-reported history of central nervous system injury or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale < 13), epilepsy, seizures, brain surgery, or any positive neuroimaging results)
- Active head lice infection, open scalp wound
- deafness, and/or blindness
- Sustained a concussion within six months
- Residual symptoms or deficits related to a previous concussion
- 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
Athletico N. LaGrange Rd
La Grange Park, Illinois, 60526
About this study
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.
The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.
- Conditions
- Minor Traumatic Brain Injury (TBI)
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 |
|---|---|---|
| Highschool athletes | Not described | |
| midschool athletes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
Measured: 1 year
Correlation of the BNA measures during the sport season in both concussed and non concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.
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 posted15 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Traumatic Brain Injury (TBI)Studies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Athletico Physical Therapy
- Responsible party
- Sponsor
- Investigators
- Mike Palm, MS,MBA, Principal investigator, Athletico Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923441
- Sponsor's protocol ID
- ELM-21
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- 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
- Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.
- ClinicalTrials.gov ID
- NCT01923441
- Acronym / sponsor ID
- ELM-21
- Conditions
- Minor Traumatic Brain Injury (TBI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Collaborators
- Athletico Physical Therapy
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Aug 2013 (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.
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.
The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Highschool athletes | – | – |
| midschool athletes | – | – |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Up to 300 athletes from Nazareth Academy, Deerfield High School and the Deerfield young warriors program athletes, from both genders, aged 10-19 years
Key inclusion criteria (1 listed)
- Athletes Ages 10-19, both genders, enrolled in Nazareth Academy , Deerfield High School or the Deerfield young warriors youth Football program .
Key exclusion criteria (6 listed)
- Self-reported history of central nervous system injury or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale < 13), epilepsy, seizures, brain surgery, or any positive neuroimaging results)
- Active head lice infection, open scalp wound
- deafness, and/or blindness
- Sustained a concussion within six months
- Residual symptoms or deficits related to a previous concussion
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 BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
Time frame: 1 year
Correlation of the BNA measures during the sport season in both concussed and non concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.
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 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.
Mike Palm, MS,MBA principal investigator
Athletico Physical Therapy
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 Minor Traumatic Brain Injury (TBI), 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 1 inclusion and 6 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 BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures. (time frame: 1 year). The study lists 2 primary outcomes in all. 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.