Clinical trial NCT03265925: Brain Network Activation Analysis in Epilepsy
Official title: Brain Network Activation Analysis in Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Epilepsy, Temporal Lobe
Lead sponsor: ElMindA Ltd
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assess the BNA database for Epilepsy population and healthy controls.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: RUSH University medical center
state: Illinois
Study officials:
name: Travis Stoub, PhD
role: PRINCIPAL_INVESTIGATOR
References: