Brain Network Activation Analysis in Epilepsy

Epilepsy Clinical Trial

Official title:

Brain Network Activation Analysis in Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265925
• Other study ID #: ELM-40
• Status: Completed
• Start date: May 26, 2017
• Est. completion date: May 8, 2018

Study information

• Verified date: September 2018
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 8, 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Locations

Country	Name	City	State
United States	RUSH University medical center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.