Overview

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

Status:
Not yet recruiting

Trial end date:
2024-08-31

Target enrollment:

Participant gender:

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....

Phase:

Phase 1

Details

Lead Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Treatments:

Manganese