Concussion, MildNCT03265912
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment
An observational study of Concussion, Mild and TBI (Traumatic Brain Injury), run by ElMindA Ltd at 2 sites in United States.
Trial summary
mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Concussion, Mild, TBI (Traumatic Brain Injury), Mild Traumatic Brain Injury
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jan 2017to 16 Jan 2018
- 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 15 to 50 years
- All sexes
- Child, Adult
Study population: Adolescents, young adults and adults of both genders, enrolled in Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2) Age range: 15-50 years
Who may be able to join
- Enrolled in Arm 1 -mTBI group in the GE study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 study
- Enrolled in Arm 2 -non TBI group in the GE study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 study
- Males and females Aged 15-50
- Willingness to participate in the companion study and the ability to give informed assent (for children) and/or consent (for the parent of a minor or adults aged 18 years of age or older for themselves).
Who cannot join
- Hair types which might preclude appropriate scalp electrode cap fit. E.g: dread locks, corn rows etc.
- Significant sensory deficit e.g.: Deafness, and/or blindness
- Open scalp wound
- Active head lice infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital for Special surery
New York, New York, 10021
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment - A GE Healthcare Companion Study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2)
mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion. Recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. This study purpose is to study this BNA technology in individuals who have sustained a concussion.
Read the detailed description
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport and Motor Vehicle accidents. The Centers for Disease Control and Prevention estimate that as many as 3.8 million sport-related concussions occur annually in the United States. Despite ongoing research, there is no highly sensitive clinical test for cognitive function that can be rapidly applied in a sporting environment. This makes the clinical diagnosis of concussion particularly difficult, as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Furthermore, with less than 10% of concussions resulting in loss of consciousness, self-reported symptom presence may be the only initial evidence of a concussion. These factors make concussion a challenging injury to diagnose. Given the variability in concussion presentations, there is no single test that can diagnose a concussion.
ElMindA, the sponsor of this study, has developed a novel method to automatically reveal functional networks of brain activity based on analysis of EEG Event Related Potential (ERP) data. This technological platform is capable of providing new metrics of brain function that can assist in patient evaluation and management. The analysis is done in two separate processes that are entirely separate and are performed independently of one another. Reference Brain Network Models of EEG data were recorded and analyzed from several groups of subjects to establish a set of group patterns that characterized the brain network activity of the group. EEG data from a single subject are processed to enable subject evaluation, as compared to the established group patterns. This individual analysis is the basis of the BNA scores computed for an individual subject.
Therefore, this investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries.
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
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 |
|---|---|---|
| Mild Traumatic Brain Injury | Subjects enrolled in the GE healthcare study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), mTBI (Mild Traumatic Brain Injury) patient group also called as Arm 1 in this study. | |
| Non Mild Traumatic Brain Injury | Subjects enrolled in the GE healthcare study, Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), non-TBI (Non Mild Traumatic Brain Injury) patients also called as Arm 2 in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.
Functional networks of brain activity is measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.
Measured: This study duration is 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start26 Jan 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265912
- Sponsor's protocol ID
- ELM-36
- Status last verified
- Sep 2018
- First submitted
- 20 Aug 2017
- Last updated
- 27 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. 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 Concussion Assessment - A GE Healthcare Companion Study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2)
- ClinicalTrials.gov ID
- NCT03265912
- Acronym / sponsor ID
- ELM-36
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- 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.
mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion. Recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. This study purpose is to study this BNA technology in individuals who have sustained a concussion.
Detailed description
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport and Motor Vehicle accidents. The Centers for Disease Control and Prevention estimate that as many as 3.8 million sport-related concussions occur annually in the United States. Despite ongoing research, there is no highly sensitive clinical test for cognitive function that can be rapidly applied in a sporting environment. This makes the clinical diagnosis of concussion particularly difficult, as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Furthermore, with less than 10% of concussions resulting in loss of consciousness, self-reported symptom presence may be the only initial evidence of a concussion. These factors make concussion a challenging injury to diagnose. Given the variability in concussion presentations, there is no single test that can diagnose a concussion.
ElMindA, the sponsor of this study, has developed a novel method to automatically reveal functional networks of brain activity based on analysis of EEG Event Related Potential (ERP) data. This technological platform is capable of providing new metrics of brain function that can assist in patient evaluation and management. The analysis is done in two separate processes that are entirely separate and are performed independently of one another. Reference Brain Network Models of EEG data were recorded and analyzed from several groups of subjects to establish a set of group patterns that characterized the brain network activity of the group. EEG data from a single subject are processed to enable subject evaluation, as compared to the established group patterns. This individual analysis is the basis of the BNA scores computed for an individual subject.
Therefore, this investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Traumatic Brain Injury | – | –Subjects enrolled in the GE healthcare study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), mTBI (Mild Traumatic Brain Injury) patient group also called as Arm 1 in this study. |
| Non Mild Traumatic Brain Injury | – | –Subjects enrolled in the GE healthcare study, Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), non-TBI (Non Mild Traumatic Brain Injury) patients also called as Arm 2 in this study. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents, young adults and adults of both genders, enrolled in Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2) Age range: 15-50 years
Key inclusion criteria (4 listed)
- Enrolled in Arm 1 -mTBI group in the GE study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 study
- Enrolled in Arm 2 -non TBI group in the GE study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 study
- Males and females Aged 15-50
- Willingness to participate in the companion study and the ability to give informed assent (for children) and/or consent (for the parent of a minor or adults aged 18 years of age or older for themselves).
Key exclusion criteria (4 listed)
- Hair types which might preclude appropriate scalp electrode cap fit. E.g: dread locks, corn rows etc.
- Significant sensory deficit e.g.: Deafness, and/or blindness
- Open scalp wound
- Active head lice infection
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
Assess the BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.
Time frame: This study duration is 12 months
Functional networks of brain activity is measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.
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 27 Sep 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild and TBI (Traumatic Brain Injury), run by ElMindA Ltd at 2 sites 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 4 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Assess the BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population. (time frame: This study duration is 12 months). 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 27 Sep 2018.