An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 11 - 15 |
| Updated: | 3/16/2015 |
| Start Date: | October 2013 |
| End Date: | July 2014 |
| Contact: | Sarah Ehlen Haecker, PhD |
| Email: | shaecker@adjuvant.com |
| Phone: | 612-202-6805 |
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.
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.
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.
1. 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.
2. Follow up visit for non-concussed athletes - non-concussed athletes will complete a
follow up visit upon completion of the sport season.
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.
1. 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.
2. Follow up visit for non-concussed athletes - non-concussed athletes will complete a
follow up visit upon completion of the sport season.
Inclusion Criteria:
- Male athletes
- aged 11-15
- enrolled in selected Minnesota Youth Hockey Programs
Exclusion Criteria:
- 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.
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