EpilepsyNCT03265925
Brain Network Activation Analysis in Epilepsy
An observational study of Epilepsy and Epilepsy, Temporal Lobe, run by ElMindA Ltd at 1 site in United States.
Trial summary
This is a prospective study investigating the utility of Brain Network Activation (BNA) analysis in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Epilepsy, Temporal Lobe
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 8 May 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from the long-term EEG monitoring floor and outpatient EEG laboratory. Controls will be recruited in response to advertisements. All participants will be given the BNA Auditory Go/NoGo task. Patient identity will be coded with a master record kept on a password protected computer in the laboratory. Deidentified data will be sent to ElMindA for scoring of the BNA test. Patient data from electronic medical records will be extracted along with patient MRI data processed.
Who may be able to join
- Participants will be between ages 18-50 years old
- 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 consent
- If corrected vision: only Glasses should be used during the study testing
Who cannot join
- History of significant head trauma
- Evidence of other neurologic disease
- Any diagnosed psychiatric or systemic condition that could lead to a change in brain activity or volume (e.g., stroke, Alzheimer's disease, alcoholism).
- Currently with lice or open wounds on scalp
- Significant sensory deficits
- Use of a hearing aid that occupies the ear canal
- Substance abuse in the last 3 months and any clinically significant substance dependency
- Additional exclusion criteria for controls are a history of any neurological disease or psychological illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
RUSH University medical center
Chicago, Illinois, 60612
About this study
This is a prospective study investigating the utility of Brain Network Activation (BNA) analysis in patients with epilepsy.
Read the detailed description
BNA technology is based on a network model to depict functional connectivity. The descriptive network model approach provides insights regarding inter-connectivity of brain networks and can describe the temporal-spatial brain activation patterns applied to various types of data-sets including EEG, MEG and fMRI.
In this study it is proposed that synchronization in brain activity may be disrupted in patients who experience frequent seizures and may correspond to functional impairments (e.g., memory, processing speed). As such, BNA analysis may provide additional data that complement current functional assessments, inform clinical assessment and management of epilepsy, and identify subgroups of patients that might be at risk for poor treatment outcomes.
- Conditions
- Epilepsy, Epilepsy, Temporal Lobe
- Medical subject headings
- Epilepsy, Epilepsy, Temporal Lobe
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 |
|---|---|---|
| Epilepsy patients Right Temporal Lobe | Epilepsy patients with seizures originating from the right temporal lobe | |
| Epilepsy patients Left Temporal Lobe | Epilepsy patients with seizures originating from the left temporal lobe | |
| Healthy | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the BNA database for Epilepsy population and healthy controls.
Functional networks of brain activity in Epilepsy (Right and Left lobe) and healthy control individuals 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 Epilepsy pathology and healthy controls.
Measured: Epilepsy subjects will perform the BNA testing at baseline prior to change in medication if applicable and 3-10 days following change in medication when applicable.
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 May 2017
- Primary completion8 May 2018
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElMindA Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Travis Stoub, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265925
- Sponsor's protocol ID
- ELM-40
- Status last verified
- Sep 2018
- First submitted
- 20 Aug 2017
- Last updated
- 27 Sep 2018
- Results posted
- 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
- Brain Network Activation Analysis in Epilepsy
- ClinicalTrials.gov ID
- NCT03265925
- Acronym / sponsor ID
- ELM-40
- Conditions
- Epilepsy, Epilepsy, Temporal Lobe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ElMindA LtdIndustry (pharma, biotech, devices)
- Study start
- 26 May 2017 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 8 May 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.
This is a prospective study investigating the utility of Brain Network Activation (BNA) analysis in patients with epilepsy.
Detailed description
BNA technology is based on a network model to depict functional connectivity. The descriptive network model approach provides insights regarding inter-connectivity of brain networks and can describe the temporal-spatial brain activation patterns applied to various types of data-sets including EEG, MEG and fMRI.
In this study it is proposed that synchronization in brain activity may be disrupted in patients who experience frequent seizures and may correspond to functional impairments (e.g., memory, processing speed). As such, BNA analysis may provide additional data that complement current functional assessments, inform clinical assessment and management of epilepsy, and identify subgroups of patients that might be at risk for poor treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients Right Temporal Lobe | – | –Epilepsy patients with seizures originating from the right temporal lobe |
| Epilepsy patients Left Temporal Lobe | – | –Epilepsy patients with seizures originating from the left temporal lobe |
| Healthy | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from the long-term EEG monitoring floor and outpatient EEG laboratory. Controls will be recruited in response to advertisements. All participants will be given the BNA Auditory Go/NoGo task. Patient identity will be coded with a master record kept on a password protected computer in the laboratory. Deidentified data will be sent to ElMindA for scoring of the BNA test. Patient data from electronic medical records will be extracted along with patient MRI data processed.
Key inclusion criteria (4 listed)
- Participants will be between ages 18-50 years old
- 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 consent
- If corrected vision: only Glasses should be used during the study testing
Key exclusion criteria (8 listed)
- History of significant head trauma
- Evidence of other neurologic disease
- Any diagnosed psychiatric or systemic condition that could lead to a change in brain activity or volume (e.g., stroke, Alzheimer's disease, alcoholism).
- Currently with lice or open wounds on scalp
- Significant sensory deficits
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 Epilepsy population and healthy controls.
Time frame: Epilepsy subjects will perform the BNA testing at baseline prior to change in medication if applicable and 3-10 days following change in medication when applicable.
Functional networks of brain activity in Epilepsy (Right and Left lobe) and healthy control individuals 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 Epilepsy pathology and healthy controls.
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.
Travis Stoub, PhD 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 Epilepsy and Epilepsy, Temporal Lobe, 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 8 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 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?
Assess the BNA database for Epilepsy population and healthy controls. (time frame: Epilepsy subjects will perform the BNA testing at baseline prior to change in medication if applicable and 3-10 days following change in medication when applicable.). 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.