Concussion, BrainNCT03249675
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults
An observational study of Concussion, Brain, run by ElMindA Ltd at 1 site in United States.
Trial summary
Concussion is widely recognized as a major public health concern in the United States and worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2017to Jan 2019
- 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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents, young adults and adults of both genders.
Who may be able to join
- Males and females Aged 12-50
- Willingness to participate in the 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).
- Subjects that are or were diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria.
- Subjects that are experiencing symptoms of concussion or Post-concussion Syndrome at the time of their initial test session.
Who cannot join
- Subjects that have undergone neuroimaging with identification of intracranial structural pathology.
- Self-reported history of central nervous system injury other than mTBI, or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale < 13) epilepsy, seizures, brain surgery)
- Neuropsychological disorder such as autistic spectrum disorder
- Any history of a learning disability (examples include, but will not be limited to, dyslexia, dysgraphia, dyscalculia, or a nonverbal learning disorder)
- Use of any medication affecting central nervous system (CNS) in the past 3 months prior to their BNA (i.e. antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.)
- Active head lice infection
Show all 9Show fewer
- Open scalp wound
- baldness, dread locks or hair that is otherwise sufficiently long and thick so as to preclude appropriate scalp electrode cap fit
- Deafness, and/or blindness
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sports Neurology Clinic at The CORE Institute
Brighton, Michigan, 48114
About this study
Official title: Clinical Trial Protocol for the Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults
Concussion is widely recognized as a major public health concern in the United States and worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. The purpose of this study is to explore the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent injury.
Read the detailed description
Mild traumatic brain injury, also known as concussion, occurs commonly in sport. The Centers for Disease Control and Prevention estimate that as many as 3.8 million sport-related concussions occur annually in the United States. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. The purpose of this study is to explore the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent injury.
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 which can assist in patient evaluation and management. The analysis is done in two separate processes which are entirely separate and are performed independently of one another. First EEG data are recorded and analyzed from a group, or several groups, of subjects to establish a set of group patterns which characterized the brain network activity of the group. Second, 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.
Primary Objective:
- Exploratory (e.g. Hypothesis-generating) study designed to collect data that will aid in future understanding of the relationship between Post Concussion Syndrome and Electrophysiology. The results are primarily intended for scientific inquiry and development purposes.
Additional objectives:
- Exploring the relationship between the characteristics of early/acute stage Mild Traumatic Brain Injury and the subsequent development of PCS
- Collecting electrophysiological and clinical data that will serve as the basis for athlete brain health case studies.
Arm 1: Study staff will contact subjects tested in the past with BNA and were diagnosed with Post-Concussion Syndrome at their medical facility.
Arm 2: Eligible subjects treated at the study medical facility for acute concussion or Post Concussion Syndrome will be approached by the study staff.
Interested volunteers will complete a brief initial in person or phone consultation with a member of the study team and those who meet eligibility criteria and wish to participate will be invited for a study visit in the testing facility. During this visit, a member of the study team will describe the study in greater detail, verify subject eligibility, obtain informed written consent/assent for study participation, and record relevant demographic, medical history information, concussion history and clinical assessment questioners as provided by the subject or as available from subject's medical records. The subject will then have the EEG electrode cap placed on their head and will undergo the BNA test after a brief training and instructional session.
- Conditions
- Concussion, Brain
- Keywords
- mild Traumatic Brain Injury, 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 |
|---|---|---|
| ARM 1 | ARM 1: Retrospective Arm: Subjects tested with BNA in the past and have been diagnosed by their physician as having Post Concussive Syndrome. Study staff will contact the subjects and obtain Informed Consent. Study physicians will then review both BNA data and Clinical data. All relevant clinical data and all available BNA data will be shared with ElMindA. Subjects may be invited for an additional BNA follow up as part of the study. | |
| ARM 2 | ARM 2: Subjects will be prospectively enrolled in the study at the following time points when available: * Acute: within 2 weeks of injury * PCS: Subjects which sustained a concussion in the past 3 months or more, and are still experiencing symptoms related to the injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a BNA database for concuss population.
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
Measured: This study duration is 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start5 Jul 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: No participant were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Kutcher, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249675
- Sponsor's protocol ID
- ELM 48
- Status last verified
- Sep 2018
- First submitted
- 8 Aug 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol for the Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults
- ClinicalTrials.gov ID
- NCT03249675
- Acronym / sponsor ID
- ELM 48
- Conditions
- Concussion, Brain
- Keywords
- mild Traumatic Brain Injury, Concussion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participant were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 15 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.
Concussion is widely recognized as a major public health concern in the United States and worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. The purpose of this study is to explore the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent injury.
Detailed description
Mild traumatic brain injury, also known as concussion, occurs commonly in sport. The Centers for Disease Control and Prevention estimate that as many as 3.8 million sport-related concussions occur annually in the United States. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. The purpose of this study is to explore the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent injury.
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 which can assist in patient evaluation and management. The analysis is done in two separate processes which are entirely separate and are performed independently of one another. First EEG data are recorded and analyzed from a group, or several groups, of subjects to establish a set of group patterns which characterized the brain network activity of the group. Second, 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.
Primary Objective:
- Exploratory (e.g. Hypothesis-generating) study designed to collect data that will aid in future understanding of the relationship between Post Concussion Syndrome and Electrophysiology. The results are primarily intended for scientific inquiry and development purposes.
Additional objectives:
- Exploring the relationship between the characteristics of early/acute stage Mild Traumatic Brain Injury and the subsequent development of PCS
- Collecting electrophysiological and clinical data that will serve as the basis for athlete brain health case studies.
Arm 1: Study staff will contact subjects tested in the past with BNA and were diagnosed with Post-Concussion Syndrome at their medical facility.
Arm 2: Eligible subjects treated at the study medical facility for acute concussion or Post Concussion Syndrome will be approached by the study staff.
Interested volunteers will complete a brief initial in person or phone consultation with a member of the study team and those who meet eligibility criteria and wish to participate will be invited for a study visit in the testing facility. During this visit, a member of the study team will describe the study in greater detail, verify subject eligibility, obtain informed written consent/assent for study participation, and record relevant demographic, medical history information, concussion history and clinical assessment questioners as provided by the subject or as available from subject's medical records. The subject will then have the EEG electrode cap placed on their head and will undergo the BNA test after a brief training and instructional session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | – | –ARM 1: Retrospective Arm: Subjects tested with BNA in the past and have been diagnosed by their physician as having Post Concussive Syndrome. Study staff will contact the subjects and obtain Informed Consent. Study physicians will then review both BNA data and Clinical data. All relevant clinical data and all available BNA data will be shared with ElMindA. Subjects may be invited for an additional BNA follow up as part of the study. |
| ARM 2 | – | –ARM 2: Subjects will be prospectively enrolled in the study at the following time points when available: * Acute: within 2 weeks of injury * PCS: Subjects which sustained a concussion in the past 3 months or more, and are still experiencing symptoms related to the injury |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents, young adults and adults of both genders.
Key inclusion criteria (4 listed)
- Males and females Aged 12-50
- Willingness to participate in the 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).
- Subjects that are or were diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria.
- Subjects that are experiencing symptoms of concussion or Post-concussion Syndrome at the time of their initial test session.
Key exclusion criteria (9 listed)
- Subjects that have undergone neuroimaging with identification of intracranial structural pathology.
- Self-reported history of central nervous system injury other than mTBI, or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale < 13) epilepsy, seizures, brain surgery)
- Neuropsychological disorder such as autistic spectrum disorder
- Any history of a learning disability (examples include, but will not be limited to, dyslexia, dysgraphia, dyscalculia, or a nonverbal learning disorder)
- Use of any medication affecting central nervous system (CNS) in the past 3 months prior to their BNA (i.e. antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.)
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
Developing a BNA database for concuss population.
Time frame: This study duration is 18 months
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
Related trials for Concussion, Brain
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
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.
Jeffrey Kutcher, MD principal investigator
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 Concussion, Brain, 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 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: withdrawn, as of the sponsor's last update on 28 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Developing a BNA database for concuss population. (time frame: This study duration is 18 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 28 Sep 2018.