Mild Traumatic Brain InjuryNCT01535339
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion
An observational study of Mild Traumatic Brain Injury, run by ElMindA Ltd at 1 site in United States.
Trial summary
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. Read more about this study
- Who is it for?
- Ages 14 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2015
- 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 14 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Phase 1: gender-balanced groups of 30 healthy high school (14-17 years old) and 30 healthy college aged (18-26 years old) individuals who participate in non-contact sports Phase 2a: 30 high school and/or collegiate athletes aged 14-26 years with concussion and 30 matched control athletes. Phase 2b: at least 30 high school and/or collegiate contact sport athletes aged 14-26 years whose head impacts are monitored during games and practices.
Who may be able to join
- Aged 14-26 years
- Enrolled in a recognized high school or college
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
- Currently participate in a non-contact sport.
- Member of an organized athletic team or regularly train for and participate in independent athletic contests during at least one sports season.
- Right handed subject
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- Aged 14-26 years.
- For Arm 1: Within 1 week post-concussion (sports-related).
- For Arm 1: Currently symptomatic
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
- Member of an organized athletic team or regularly train.
- Enrolled in a high school or college.
- Aged 14-26 years.
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
- Member of a contact sport team which carries out head impact monitoring over the course of the playing season.
- Enrolled in a high school or college.
Who cannot join
- Currently participate in a contact sport.
- Bald or has dread locks/long and thick hair.
- Any diagnosed psychiatric disorder
- History of CNS injury or disease
- Any neuropsychological disorders
- History of learning disability.
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- History of any medication affecting CNS.
- Active head lice infection, open scalp wound, deafness or/and blindness.
- Sustained a diagnosed concussion within the previous 6 months
- Phase 2a:
- Bald or has dread locks/long and thick hair.
- Current or history of ADHD.
- Active head lice infection, open scalp wound, deafness or/and blindness.
- Sustained a concussion within the past 6 months.
- Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery.
- Phase 2b:
- Bald or has dread locks/long and thick hair.
- Current or history of ADHD.
- Active head lice infection, open scalp wound, deafness or/and blindness.
- Sustained a concussion within the past 6 months.
- Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery.
- Any diagnosed psychiatric disorder.
- History of CNS injury or disease
- Any neuropsychological disorders.
- History of learning disability.
- History of any medication affecting CNS.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan NeuroSport Concussion Program
Ann Arbor, Michigan, 48105
About this study
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment.
This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mild Traumatic Brain Injury, mTBI, 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 |
|---|---|---|
| Phase I - Normative | Athletes who does not participate in contact sport with no recent concussion | |
| Phase IIa - Concussed | Athletes with recent concussion | |
| Phase IIa - Control | Athletes with no recent concussion | |
| Phase IIb - Athletes | Athletes with no recent concussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Brain Network Activation(BNA™)Scores
Measured: P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Secondary outcomes (3)
Correlation Of The Change In BNA™ Scores To Clinical Diagnstic
Measured: P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scroes
Measured: P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Correlation Of The Change In BNA™ Scores To Reaction Time Scores
Measured: P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535339
- Sponsor's protocol ID
- ELM-03
- Status last verified
- Sep 2019
- First submitted
- 12 Feb 2012
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion
- ClinicalTrials.gov ID
- NCT01535339
- Acronym / sponsor ID
- ELM-03
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mild Traumatic Brain Injury, mTBI, Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Feb 2012 (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.
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment.
This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I - Normative | – | –Athletes who does not participate in contact sport with no recent concussion |
| Phase IIa - Concussed | – | –Athletes with recent concussion |
| Phase IIa - Control | – | –Athletes with no recent concussion |
| Phase IIb - Athletes | – | –Athletes with no recent concussion |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Phase 1: gender-balanced groups of 30 healthy high school (14-17 years old) and 30 healthy college aged (18-26 years old) individuals who participate in non-contact sports Phase 2a: 30 high school and/or collegiate athletes aged 14-26 years with concussion and 30 matched control athletes. Phase 2b: at least 30 high school and/or collegiate contact sport athletes aged 14-26 years whose head impacts are monitored during games and practices.
Key inclusion criteria (16 listed)
- Aged 14-26 years
- Enrolled in a recognized high school or college
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
- Currently participate in a non-contact sport.
- Member of an organized athletic team or regularly train for and participate in independent athletic contests during at least one sports season.
Key exclusion criteria (26 listed)
- Currently participate in a contact sport.
- Bald or has dread locks/long and thick hair.
- Any diagnosed psychiatric disorder
- History of CNS injury or disease
- Any neuropsychological disorders
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
Change of Brain Network Activation(BNA™)Scores
Time frame: P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
3 secondary outcomes
Correlation Of The Change In BNA™ Scores To Clinical Diagnstic
Time frame: P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scroes
Time frame: P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
Correlation Of The Change In BNA™ Scores To Reaction Time Scores
Time frame: P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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 25 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mild Traumatic Brain Injury, run by ElMindA Ltd at 1 site in United States.
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 16 inclusion and 26 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 25 Sep 2019. 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 United States. 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?
Change of Brain Network Activation(BNA™)Scores (time frame: P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season). 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 25 Sep 2019; AzTrials last refreshed its copy on 27 Oct 2026.