- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02132507
Multimodal Functional Neuroimaging in Epilepsy Patients
Study Overview
Status
Conditions
Detailed Description
MRI is a clinical routine test for imaging (creating a picture) of the structure and function of human organs using a giant magnet and other electronic and computing equipment. Functional MRI (fMRI) is an MRI that is done while the subject performs some simple activity or in resting state. It shows the areas of the brain that are activated by performing each of these activities or correlated with spontaneous brain activities (e.g. interictal spikes).
The EEG-fMRI session will be conducted at the University of Minnesota Center for Magnetic Resonance Research. If a subject has any metal implant in his/her body, s/he must not participate in the MRI test. After subjects pass through the routine screening for participation in the MRI test, an EEG cap with 64 electrodes will be put on his/her scalp and electrically conducting gels will be applied to each of these electrodes. One more electrode will be put on his/her back to record electrocardiographic signal. The electrodes location will be recorded by means of a device which can tell the positions of the electrode sensors. The EEG preparation procedure will take around 30-45 minutes. Then a 15-minute EEG will be recorded out side of the scanner. Afterwards, the subject will be asked to lie down in a MRI scanner with the EEG cap on his/her scalp. The electrodes will be connected to a data collection system and electroencephalograms and fMRI will be collected and stored simultaneously onto the computer of the recording system. During the scan, subjects will be asked to close his/her eyes but keep awake. Or subjects may be also asked to perform some simple tasks. For example, subjects may be asked to tap his/her finger regularly or imagine some movements. The EEG-fMRI scan will take around 2 hours. After the recording session, subjects may want to wash his/her hair to clean out the electrically conductive gels. Although the EEG and MRI procedure can be performed as a routine clinical test, in this instance it is being performed for the research and not for his/her clinical care.
Subjects may also be asked to undergo EEG or fMRI recordings separately. In this case, subjects will be asked to perform similar simple tasks as those during EEG-fMRI procedure. The total time involved with either the special EEG session or the MRI (or MRI-EEG) session will be about one to two hours.
Approximately 50 subjects may be involved in this research at the University of Minnesota.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Biomedical Engineering Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1. Patients are diagnosed with medically intractable epilepsy;
- 2. patients have frequent interictal spikes on clinical EEG monitorings;
- 3. patients without large morphological abnormalities
Exclusion Criteria:
- Patients with skull bony defects, intracerebral mass lesions, major brain malformations, large cystic regions will be excluded.
- Any indwelling metal objects or implantable devices such as pace makers, cochlear implants, or implanted intracranial electrodes.
- Patients with claustrophobia.
- Patients with more than 2 grand mal seizures per month.
- Patients will not be excluded on the basis of location of seizure onset zone, type or number of medications, or cognitive status (assuming the minimum criteria has been met), or race.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Localization of epileptogenic foci
Time Frame: 12/31/2014
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Finding of epileptogenic foci in patients with focal epilepsy
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12/31/2014
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bin He, PhD, Distinguished McKnight University Professor of Biomedical Engineering Medtronic-Bakken Chair for Engineering in Medicine Director, Institute for Engineering in Medicine Director, Center for Neuroengineering
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01EB006433 (U.S. NIH Grant/Contract)
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.
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