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- Klinische proef NCT01759173
Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in the College Age 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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M3J 1P3
- York University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school.
Exclusion Criteria:
Current or history of any of the following:
- TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- Any psychiatric disorder
- Any Neurological disorder
- Substance abuse
- Special education
- Any medication affecting CNS
- Significant sensory deficits such as deafness or blindness
- Residual symptoms or deficits related to a previous concussion
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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college athletes
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Changes in BNA™ measures during the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
Tijdsspanne: an average of 1 year
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an average of 1 year
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Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis.
Tijdsspanne: an average of 1 year
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an average of 1 year
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To assess the clinical utility of changes in BNA in assisting with clinical decision-making.
Tijdsspanne: an average of 1 year
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an average of 1 year
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Mazyar Fallah, PhD, York University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ELM-18
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