NormativeNormativeNCT02418208
Normative Data Base of Brain Network Activation (BNA) Using Evoked Response Potentials
An observational study of Normative, run by ElMindA Ltd at 5 sites in 2 countries.
Trial summary
Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked response potentials in adolescents, young adults and Adults. Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to 1500 subjects will be enrolled in 4 or more sites. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normative
- What is being tested?
- Performint EEG tests and BNA analysis
- How many people
- 964 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Mar 2015to Nov 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Up to 1500 subjects, from both genders, aged 10 years and above will be recruited, stratified to age groups.
Who may be able to join
- Age 10-years and above.
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
- 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
- Has participated in the past 6 months in an organized contact sport activity (e.g., football, hockey, soccer, rugby, lacrosse, martial arts, Boxing).
- Currently with lice or open wounds on scalp.
- Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history or PI discretion.
- Active (within 1 month) Migraine history or clinically significant reoccurring Migraine episodes.
- Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
- Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
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- Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. as determined by clinical evaluation
- History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
- History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc. The investigator should consider including subjects which had used such drugs for a short period according to a logical calculation of the drug's half-life.
- Substance abuse in the last 3 months and any clinically significant substance dependency as determined by the MINI evaluation and PI discretion.
- Significant sensory deficits, e.g., deafness or blindness.
- Pregnant women or women that are 1 month following a childbirth.
- History of any clinically significant brain trauma as determined by the investigator.
- History of more than 1 clinically diagnosed concussion.
- Clinically diagnosed with a concussion in the past year. Minor deviations to eligibility criteria may be made on a case-by-case basis prior to enrollment if approved by the Sponsor, in writing, in agreement with the Investigator.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Ohio Clinical Trials, Inc.
Columbus, Ohio, 43212
Clinical trials of the Rockies, Inc.
Denver, Colorado, 80209
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Psychiatric Medicine Associates, Llc
Skokie, Illinois, 60076
About this study
Official title: Clinical Trial Protocol for the Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents, Young Adults and Adults
Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked response potentials in adolescents, young adults and Adults.
Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to 1500 subjects will be enrolled in 4 or more sites. Study duration: Each patient will be followed up for up to 1 year. Overall study duration will be up to 1.5 years. Patient population: Adolescents, young adults and Adults of both genders.
Age range:
- 10-11.99
- 12-13.99
- 14-15.99
- 16-17.99
- 18-24.99
- 25-29.99
- 30-34.99
- 35-39.99
- 40-44.99
- 45-49.99
- 50-54.99
- 55-60
- 60 and above
Objective: Establishment of normative data of BNA.
Read the detailed description
Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. 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 non-invasive 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 need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.
- Conditions
- Normative
- Being tested
- Performint EEG tests and BNA analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performint EEG tests and BNA analysisDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Test retest- 2 visits | Eligible participants will arrive for 2 testing visits a week apart and an optional third visit within 6-12 months. Receives: Diagnostic Test: Performint EEG tests and BNA analysis | |
| Single Visit | Eligible participants will arrive for a single testing visit Receives: Diagnostic Test: Performint EEG tests and BNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a BNA database for normative population.
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2017
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormativeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 964 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
- NCT02418208
- Sponsor's protocol ID
- ELM-25
- Acronym
- Normative
- Status last verified
- Nov 2019
- First submitted
- 8 Apr 2015
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol for the Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents, Young Adults and Adults
- ClinicalTrials.gov ID
- NCT02418208
- Acronym / sponsor ID
- Normative / ELM-25
- Conditions
- Normative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 964 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 16 Apr 2015 (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.
Purpose: EEstablish normative data of ElMindA's Brain Network Activation (BNA) using evoked response potentials in adolescents, young adults and Adults.
Trial design: Open, one-arm, prospective, age-stratified, multi site. Enrollment size: Up to 1500 subjects will be enrolled in 4 or more sites. Study duration: Each patient will be followed up for up to 1 year. Overall study duration will be up to 1.5 years. Patient population: Adolescents, young adults and Adults of both genders.
Age range:
- 10-11.99
- 12-13.99
- 14-15.99
- 16-17.99
- 18-24.99
- 25-29.99
- 30-34.99
- 35-39.99
- 40-44.99
- 45-49.99
- 50-54.99
- 55-60
- 60 and above
Objective: Establishment of normative data of BNA.
Detailed description
Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. 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 non-invasive 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 need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test retest- 2 visits | – | Diagnostic Test: Performint EEG tests and BNA analysisEligible participants will arrive for 2 testing visits a week apart and an optional third visit within 6-12 months. |
| Single Visit | – | Diagnostic Test: Performint EEG tests and BNA analysisEligible participants will arrive for a single testing visit |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 1500 subjects, from both genders, aged 10 years and above will be recruited, stratified to age groups.
Key inclusion criteria (3 listed)
- Age 10-years and above.
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
- 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 (15 listed)
- Has participated in the past 6 months in an organized contact sport activity (e.g., football, hockey, soccer, rugby, lacrosse, martial arts, Boxing).
- Currently with lice or open wounds on scalp.
- Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history or PI discretion.
- Active (within 1 month) Migraine history or clinically significant reoccurring Migraine episodes.
- Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performint EEG tests and BNA analysis | Diagnostic test | Single Visit, Test retest- 2 visits |
Primary outcome
Developing a BNA database for normative population.
Time frame: 1.5 years
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data
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 26 Nov 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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normative, run by ElMindA Ltd at 5 sites in 2 countries.
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 3 inclusion and 15 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, India. 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?
Developing a BNA database for normative population. (time frame: 1.5 years). 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 26 Nov 2019.