Multimodal Functional Neuroimaging in Epilepsy Patients

Epilepsy Clinical Trial

Official title:

Multimodal Functional Neuroimaging in Epilepsy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132507
• Other study ID #: R01EB006433
• Secondary ID: R01EB006433
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: January 18, 2018
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: January 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to evaluate a new technology for functional neuroimaging using electroencephalography (EEG) and MRI in studying epilepsy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Biomedical Engineering Department	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Localization of epileptogenic foci	Finding of epileptogenic foci in patients with focal epilepsy	12/31/2014