Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Epilepsy Clinical Trial

Official title: Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Status Recruiting

Clinical Trial Summary

Background:

• The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects.

Objective:

• To see if mangafodipir is well tolerated and safe. To see if it can show, on an MRI, areas of the brain that epilepsy affects.

Eligibility:

• People ages 18-60 who:

• Have epilepsy not controlled by drugs

• Prior or concurrent enrollment in 18-N-0066 is required

Design:

• Participants will be screened with:

• Medical history

• Physical exam

• Blood and urine tests

• Participants will have up to 6 visits in 1-3 months. Those with epilepsy will have an inpatient stay lasting 2-10 days. Visits may include:

• Video-EEG monitoring for participants with epilepsy

• An IV catheter put in place: a needle guides a thin plastic tube into an arm vein.

• Getting mangafodipir through the IV.

• 5 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides into a metal cylinder. They are in the cylinder for 45-90 minutes, lying still for up to 10 minutes at a time. The scanner makes loud knocking sounds. Participants will get earplugs.

• A final MRI at least 2 weeks after receiving mangafodipir. Gadolinium is given through an IV catheter.

Clinical Trial Description

Objective:

The primary goals of this pilot study are to (1) describe the safety profile of administration of mangafodipir in patients with epilepsy and (2) investigate the prevalence of blood-brain barrier disruption (BBBD) in patients with drug-resistant focal epilepsy using peri-ictal manganese enhanced magnetic resonance imaging (MEMRI) and interictal gadolinium dynamic contrast-enhanced MRI (DCE-MRI) and determine if these methods will allow for visualization of seizure foci. Secondary objectives are further exploration of MEMRI and DCE-MRI properties in patients with epilepsy.

Study population:

40 patients with drug-resistant epilepsy.

Design:

Screening of enrolled participants will include a medical history, physical exam, blood and urine laboratory testing. Patients will be imaged interictally with a gadolinium enhanced MRI session. The administration of mangafodipir will be done as an inpatient during long-term video EEG recording, to ensure administration in the periictal period. Patients will receive a baseline MRI scan, IV mangafodipir injection and will then be serially scanned with non-contrast MRI scans.

Outcome measures:

The primary outcomes are (1) description of the safety profile of mangafodipir administration in patients with epilepsy, and (2) evaluation of the utility of MEMRI and/or DCE-MRI in identifying focal BBBD in the seizure onset zone identified by standard clinical, EEG, and imaging studies, and the homologous contralateral region. ;

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

• NCT number: NCT02531880
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Aaliyah H HamidullahThiam
• Phone: (301) 402-7686
• Email: aaliyah.hamidullahthiam@nih.gov
• Status: Recruiting
• Phase: Phase 1
• Start date: July 6, 2024
• Completion date: July 1, 2025