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Brain Network Activation Analysis in Epilepsy

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ClinicalTrials.gov Identifier: NCT03265925
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd

Brief Summary:
This is a prospective study investigating the utility of Brain Network Activation (BNA) analysis in patients with epilepsy.

Condition or disease
Epilepsy Epilepsy, Temporal Lobe

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 Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Network Activation Analysis in Epilepsy
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : May 8, 2018
Actual Study Completion Date : May 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265925


Locations
United States, Illinois
RUSH University medical center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
ElMindA Ltd
Investigators
Principal Investigator: Travis Stoub, PhD

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT03265925     History of Changes
Other Study ID Numbers: ELM-40
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial