Brain Network Activation Analysis in Epilepsy

NCT03265925 | Completed

• 1 other identifier: ELM-40
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy; Epilepsy, Temporal Lobe

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

RUSH University medical center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Epilepsy; Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsies, Partial; Epileptic Syndromes

Study Officials

• Travis Stoub, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 29, 2017
• Study Start: May 26, 2017
• Primary Completion: May 8, 2018
• Study Completion: May 8, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

US (1)