HealthyNCT01963247
An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
An observational study of Healthy and 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 11 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Minor Traumatic Brain Injury (TBI)
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 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 11 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Study population: 150 male athletes enrolled in Minnesota Youth Hockey Programs, aged 11-15 years.
Who may be able to join
- Male athletes
- aged 11-15
- enrolled in selected Minnesota Youth Hockey Programs
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
- A concussion within prior 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
Noran Neurological Clinic
Minneapolis, Minnesota, 55407
About this study
Official title: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth Athletes
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.
The BNA test is basically divided to 3 phases - first EEG data is collected from subjects using an EEG system while the subject is performing a cognitive task in front of a computer. The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the BNA™ test is generated.
Read the detailed description
A single center study evaluating the effectiveness of BNA technology as an objective tool for sport related concussion management in youth athletes' populations.
The study will include 150 athletes from Minnesota Youth Hockey Programs. Subjects enrolled in this study will undergo a screening and baseline pre season visit and follow up visit/s.
- Follow-up testing for concussed athletes - Concussed athletes will complete a series of post concussion follow up visits. Each will consist of BNA™ test, ImPACT™ test, and exam by neurologist or neurology nurse practitioner. The first visit will be within 72 hours of injury and re-evaluations will occur weekly until BNA has normalized AND subject is asymptomatic. Subject may return to play at that point and subject will have a final additional BNA™ test one week after the athlete returns to full activity. If participant is still symptomatic and/or BNA is still abnormal at 6 weeks reevaluations go to every 2 weeks for up to three months or clearing of symptoms AND normal BNA™. If not back to baseline at three months, monthly reevaluations until study completion.
- Follow up visit for non-concussed athletes - non-concussed athletes will complete a follow up visit upon completion of the sport season.
- Conditions
- Healthy, 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 |
|---|---|---|
| Healthy Athletes | Not described | |
| Concussed 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
Consistency or changes in BNA™ measures during and after 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 concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.
Correlation of the BNA measures during the sport season in 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 posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Noran Neurological Clinic
- Responsible party
- Sponsor
- Investigators
- Steven s Lebow, MD, Principal investigator, Noran Neurological Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963247
- Sponsor's protocol ID
- ELM-22
- Status last verified
- Apr 2015
- First submitted
- 10 Oct 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 Athletes
- ClinicalTrials.gov ID
- NCT01963247
- Acronym / sponsor ID
- ELM-22
- Conditions
- Healthy, Minor Traumatic Brain Injury (TBI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Collaborators
- Noran Neurological Clinic
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Oct 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.
The BNA test is basically divided to 3 phases - first EEG data is collected from subjects using an EEG system while the subject is performing a cognitive task in front of a computer. The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the BNA™ test is generated.
Detailed description
A single center study evaluating the effectiveness of BNA technology as an objective tool for sport related concussion management in youth athletes' populations.
The study will include 150 athletes from Minnesota Youth Hockey Programs. Subjects enrolled in this study will undergo a screening and baseline pre season visit and follow up visit/s.
- Follow-up testing for concussed athletes - Concussed athletes will complete a series of post concussion follow up visits. Each will consist of BNA™ test, ImPACT™ test, and exam by neurologist or neurology nurse practitioner. The first visit will be within 72 hours of injury and re-evaluations will occur weekly until BNA has normalized AND subject is asymptomatic. Subject may return to play at that point and subject will have a final additional BNA™ test one week after the athlete returns to full activity. If participant is still symptomatic and/or BNA is still abnormal at 6 weeks reevaluations go to every 2 weeks for up to three months or clearing of symptoms AND normal BNA™. If not back to baseline at three months, monthly reevaluations until study completion.
- Follow up visit for non-concussed athletes - non-concussed athletes will complete a follow up visit upon completion of the sport season.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Athletes | – | – |
| Concussed Athletes | – | – |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 150 male athletes enrolled in Minnesota Youth Hockey Programs, aged 11-15 years.
Key inclusion criteria (3 listed)
- Male athletes
- aged 11-15
- enrolled in selected Minnesota Youth Hockey Programs
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
- A concussion within prior 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
Time frame: 1 year
Consistency or changes in BNA™ measures during and after the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
Correlation of the BNA measures during the sport season in concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.
Time frame: 1 year
Correlation of the BNA measures during the sport season in concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.
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.
Steven s Lebow, MD principal investigator
Noran Neurological Clinic
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 Healthy and 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 3 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 (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.