- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Ontario
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Toronto, Ontario, Kanada, M3J 1P3
- York University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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college athletes
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
Tidsram: 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.
Tidsram: an average of 1 year
|
an average of 1 year
|
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To assess the clinical utility of changes in BNA in assisting with clinical decision-making.
Tidsram: an average of 1 year
|
an average of 1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Mazyar Fallah, PhD, York University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ELM-18
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