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

Epilepsy Clinical Trial

Official title:

EEG-triggered fMRI in Epilepsy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193932
• Other study ID #: 12-100
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: July 30, 2019

Study information

• Verified date: September 2019
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• EEG Triggered fMRI using Micro Maglink

Locations

Country	Name	City	State
United States	Baptist Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with at least 40 interictal epileptic discharges during the fMRI		1 year