Electroencephalogram (EEG) Triggered Functional Magnetic Resonance Imaging (fMRI) in Epilepsy Patients

NCT ID: NCT02193932

Last Updated: 2019-09-20

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

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-01

Study Completion Date

2019-07-30

Brief Summary

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A prospective exploratory study in patients with drug resistant epilepsy with a target comparison of long term outcome. NeuroScan software modules and a MagLink will be used to acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the MRI machine, without compromising the raw EEG data.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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EEG Triggered fMRI using Micro Maglink

EEG Triggered fMRI to be performed using the Micro Maglink

Group Type EXPERIMENTAL

EEG Triggered fMRI using Micro Maglink

Intervention Type OTHER

Interventions

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EEG Triggered fMRI using Micro Maglink

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Refractory epilepsy cases, referred by the service of Neurology. These are cases whose pathophysiology is resistant to treatment, including change in medication and or added medication.
2. Patients will be included if they agree to sign an Institutional Review Board approved written consent.

Exclusion Criteria

1. Patients with overt symptoms or signs of anxiety than cannot cooperate during the recording inside the scanner, unless consent is given for the procedure to be performed with sedation by the anesthesia department.
Minimum Eligible Age

1 Year

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baptist Health South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergio Gonzalez-Arias, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Health South Florida

Locations

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Baptist Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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12-100

Identifier Type: -

Identifier Source: org_study_id

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