Traumatic Brain InjuryNCT01532271
Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults
An observational study of Traumatic Brain Injury, run by ElMindA Ltd at 1 site in United States.
Trial summary
The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. Read more about this study
- Who is it for?
- Ages 14 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Mar 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 14 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Experimental subjects will include males and females with a recent sports-related concussion (less than 10 days post-concussion) recruited from approximately 50 high schools and colleges with UPMC-affiliated certified athletic trainers (ATC) on staff and from patients at the UPMC Sports Medicine Concussion Program.
Who may be able to join
- Aged 14-27 years
- Arm 1 only (Concussed): Over 2 days and below 10 days post-concussion (sports-related)
- 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)
Who cannot join
- TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- Any psychiatric disorder
- Substance abuse
- Special education
- Any Neurological disorder
- Any medication affecting CNS
Show all 11Show fewer
- Significant sensory deficits such as deafness or blindness
- Clinically significant abnormal laboratory values or ECG
- A history of more than 3 concussions in the past
- A concussion within the last year
- Residual symptoms or deficits related to a previous concussion
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Sports Medicine Concussion Program
Pittsburgh, Pennsylvania, 15203
About this study
Official title: Comparison of Brain Network Activation Analysis (BNA™) Using Evoked Response Potentials, Clinical Symptoms and Neuro-cognitive Performance and Symptoms in Concussed Children, Young Adults and Matched Controls
The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. However, little is known about the immediate changes in brain activity in specific brain regions and connectivity across them associated with performance on specific neurocognitive tests following a concussion, and the subsequent changes over time. The proposed study will provide initial evidence for the feasibility of an ERP based biomarker for concussion reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion.
- Conditions
- Traumatic Brain Injury
- Keywords
- mild Traumatic Brain Injury, mTBI, Concussion
- Medical subject headings
- Brain Injuries, Traumatic, 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 |
|---|---|---|
| Concussed | Patients with recent concussion | |
| Matched controls | 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 Over Post Concussion Recovery Period
Measured: days 2-10, 7-19, 12-28, 17-37 following concussion
Secondary outcomes (1)
Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scores and Clinical Diagnostic
Measured: days 2-10, 7-19, 12-28, 17-37 following concussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony P. Kontos, Ph.D., Principal investigator, UPMC Sports Medicine Concussion ProgramMichael W. Collins, Ph.D., Principal investigator, UPMC Sports Medicine Concussion Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532271
- Sponsor's protocol ID
- ELM-01
- Status last verified
- Sep 2019
- First submitted
- 7 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
- Comparison of Brain Network Activation Analysis (BNA™) Using Evoked Response Potentials, Clinical Symptoms and Neuro-cognitive Performance and Symptoms in Concussed Children, Young Adults and Matched Controls
- ClinicalTrials.gov ID
- NCT01532271
- Acronym / sponsor ID
- ELM-01
- Conditions
- Traumatic Brain Injury
- Keywords
- mild Traumatic Brain Injury, mTBI, Concussion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 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.
The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. However, little is known about the immediate changes in brain activity in specific brain regions and connectivity across them associated with performance on specific neurocognitive tests following a concussion, and the subsequent changes over time. The proposed study will provide initial evidence for the feasibility of an ERP based biomarker for concussion reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed | – | –Patients with recent concussion |
| Matched controls | – | –Athletes with no recent concussion |
Who may qualify
- Ages
- 14 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Experimental subjects will include males and females with a recent sports-related concussion (less than 10 days post-concussion) recruited from approximately 50 high schools and colleges with UPMC-affiliated certified athletic trainers (ATC) on staff and from patients at the UPMC Sports Medicine Concussion Program.
Key inclusion criteria (4 listed)
- Aged 14-27 years
- Arm 1 only (Concussed): Over 2 days and below 10 days post-concussion (sports-related)
- 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)
Key exclusion criteria (11 listed)
- TBI (i.e., Glasgow Coma Scale <13) or brain surgery
- Any psychiatric disorder
- Substance abuse
- Special education
- Any Neurological disorder
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 Over Post Concussion Recovery Period
Time frame: days 2-10, 7-19, 12-28, 17-37 following concussion
1 secondary outcome
Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scores and Clinical Diagnostic
Time frame: days 2-10, 7-19, 12-28, 17-37 following concussion
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.
Anthony P. Kontos, Ph.D. principal investigator
UPMC Sports Medicine Concussion Program
Michael W. Collins, Ph.D. principal investigator
UPMC Sports Medicine Concussion Program
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 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 4 inclusion and 11 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 Over Post Concussion Recovery Period (time frame: days 2-10, 7-19, 12-28, 17-37 following concussion). 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.