Brain Network Activation Analysis in Epilepsy

NCT ID: NCT03265925

Last Updated: 2018-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-26

Study Completion Date

2018-05-08

Brief Summary

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

Detailed Description

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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

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Epilepsy Epilepsy, Temporal Lobe

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epilepsy patients Right Temporal Lobe

Epilepsy patients with seizures originating from the right temporal lobe

No interventions assigned to this group

Epilepsy patients Left Temporal Lobe

Epilepsy patients with seizures originating from the left temporal lobe

No interventions assigned to this group

Healthy

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ElMindA Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Travis Stoub, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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RUSH University medical center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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ELM-40

Identifier Type: -

Identifier Source: org_study_id

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