Minor Traumatic Brain Injury (TBI)NCT01759173
Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
An observational study of Minor Traumatic Brain Injury (TBI), run by ElMindA Ltd at 1 site in Canada.
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 17 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Minor Traumatic Brain Injury (TBI)
- How many people
- 234 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to 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 17 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 200-300 athletes from 3-9 college sport teams, from both genders, aged 17-24 years.
Who may be able to join
- Age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school.
Who cannot join
- 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
Show all 9Show fewer
- Any medication affecting CNS
- Significant sensory deficits such as deafness or blindness
- Residual symptoms or deficits related to a previous concussion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Minor Traumatic Brain Injury (TBI)
- Keywords
- Minor traumatic brain injury (TBI), Concussion
- Medical subject headings
- Brain Concussion
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 |
|---|---|---|
| college 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 in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
Measured: an average of 1 year
Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis.
Measured: an average of 1 year
To assess the clinical utility of changes in BNA in assisting with clinical decision-making.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startSep 2012
- 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 Minor Traumatic Brain Injury (TBI)Studies 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
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- York University
- Responsible party
- Sponsor
- Investigators
- Mazyar Fallah, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759173
- Sponsor's protocol ID
- ELM-18
- Status last verified
- Apr 2015
- First submitted
- 3 Dec 2012
- 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
- Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in the College Age Athletes
- ClinicalTrials.gov ID
- NCT01759173
- Acronym / sponsor ID
- ELM-18
- Conditions
- Minor Traumatic Brain Injury (TBI)
- Keywords
- Minor traumatic brain injury (TBI), Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Collaborators
- York University
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jan 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| college athletes | – | – |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 200-300 athletes from 3-9 college sport teams, from both genders, aged 17-24 years.
Key inclusion criteria (1 listed)
- Age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school.
Key exclusion criteria (9 listed)
- TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- Any psychiatric disorder
- Any Neurological disorder
- Substance abuse
- Special education
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 in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.
Time frame: an average of 1 year
Correlation of the BNA measures in both concussed and non concussed athletes to the clinical diagnosis.
Time frame: an average of 1 year
To assess the clinical utility of changes in BNA in assisting with clinical decision-making.
Time frame: an average of 1 year
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.
Related trials for Minor Traumatic Brain Injury (TBI)
RecruitingObservational study
Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma
Craniocerebral Trauma, Brain Injuries, Traumatic
Not yet recruitingObservational study
Using Routine Inflammatory and Metabolic Blood Tests (Bedside Included) to Predict Brain Injury in Children After Minor Head Trauma
Brain Injury Traumatic Mild
Active, not recruiting
Hypertonic Saline for Mild TBI in Pediatric Patients
Head Injury, Minor, Pediatric
RecruitingObservational study
Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Brain Injuries, Traumatic
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.
Mazyar Fallah, PhD principal investigator
York University
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 Minor Traumatic Brain Injury (TBI), run by ElMindA Ltd at 1 site in Canada.
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 1 inclusion and 9 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 Canada. 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 in both concussed and non concussed athletes compared to pre season BNA™ baseline measures. (time frame: an average of 1 year). The study lists 3 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.