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

September 19, 2019 updated by: Baptist Health South Florida

EEG-triggered fMRI in Epilepsy Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33173
        • Baptist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  2. Patients who meet the regular exclusion criteria for Magnetic Resonance Imaging (MRI) studies per the prescreening form reviewed with all patients prior to exams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EEG Triggered fMRI using Micro Maglink
EEG Triggered fMRI to be performed using the Micro Maglink
Other: EEG Triggered fMRI using Micro Maglink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with at least 40 interictal epileptic discharges during the fMRI
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Investigators

  • Principal Investigator: Sergio Gonzalez-Arias, MD, Baptist Health South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe