Back to resultsElectroencephalogram (EEG) Triggered Functional Magnetic Resonance Imaging (fMRI) in Epilepsy Patients
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EEG Triggered fMRI using Micro Maglink
Sponsored by
About this trial
This is an interventional health services research trial for Epilepsy focused on measuring EEG triggered, fMRI, epilepsy, intractable
Eligibility Criteria
Inclusion Criteria:
- 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.
- Patients will be included if they agree to sign an Institutional Review Board approved written consent.
Exclusion Criteria:
- 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.
- Patients who meet the regular exclusion criteria for Magnetic Resonance Imaging (MRI) studies per the prescreening form reviewed with all patients prior to exams
Sites / Locations
- Baptist Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EEG Triggered fMRI using Micro Maglink
Arm Description
EEG Triggered fMRI to be performed using the Micro Maglink
Outcomes
Primary Outcome Measures
Number of participants with at least 40 interictal epileptic discharges during the fMRI
Secondary Outcome Measures
Full Information
NCT ID
NCT02193932
First Posted
July 10, 2014
Last Updated
September 19, 2019
Sponsor
Baptist Health South Florida
1. Study Identification
Unique Protocol Identification Number
NCT02193932
Brief Title
Electroencephalogram (EEG) Triggered Functional Magnetic Resonance Imaging (fMRI) in Epilepsy Patients
Official Title
EEG-triggered fMRI in Epilepsy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
EEG triggered, fMRI, epilepsy, intractable
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EEG Triggered fMRI using Micro Maglink
Arm Type
Experimental
Arm Description
EEG Triggered fMRI to be performed using the Micro Maglink
Intervention Type
Other
Intervention Name(s)
EEG Triggered fMRI using Micro Maglink
Primary Outcome Measure Information:
Title
Number of participants with at least 40 interictal epileptic discharges during the fMRI
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Patients will be included if they agree to sign an Institutional Review Board approved written consent.
Exclusion Criteria:
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.
Patients who meet the regular exclusion criteria for Magnetic Resonance Imaging (MRI) studies per the prescreening form reviewed with all patients prior to exams
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Gonzalez-Arias, MD
Organizational Affiliation
Baptist Health South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Electroencephalogram (EEG) Triggered Functional Magnetic Resonance Imaging (fMRI) in Epilepsy Patients
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