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

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Other: EEG Triggered fMRI using Micro Maglink

• Registration Number: NCT02193932
• Lead Sponsor: Baptist Health South Florida

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-02-01
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EEG Triggered fMRI using Micro Maglink	EEG Triggered fMRI using Micro Maglink	EEG Triggered fMRI to be performed using the Micro Maglink

Primary Outcome Measures

Name	Time	Method
Number of participants with at least 40 interictal epileptic discharges during the fMRI	1 year

Trial Locations

Locations (1)

Baptist Hospital; 🇺🇸 Miami, Florida, United States