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NCT01963247 · ClinicalTrials.gov registry record
An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
A clinical trial, sponsored by ElMindA.
- Completed
- Registry status
- 145
- Enrollment target
NCT01963247: Completed study, sponsored by ElMindA.
NCT01963247 is a clinical trial that has completed, run by ElMindA. The registered enrollment target is 145 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01963247 has completed, sponsored by ElMindA.
- COMPLETED
- Registry status
- 145 participants
- Enrollment target
Study 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 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-12 |
What the finished NCT01963247 record still lists
NCT01963247 is an observational study that tracks outcomes without assigning an intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01963247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01963247 about?
NCT01963247 is a clinical study titled "An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion". 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 i...
What is the current status of trial NCT01963247?
This trial is currently completed. The enrollment target is 145 participants. The study started on 2013-10. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01963247?
This trial is sponsored by ElMindA, which has 12 total clinical trials registered on ClinicalTrials.gov.
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