Actively Recruiting
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-01
40
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-60 years
- Able to give written informed consent directly
- Drug-resistant epilepsy with documented seizures and consistent EEG evidence
- Refractory to standard anti-seizure treatment for at least one year
- Average of at least one seizure per month
- Prior or concurrent enrollment in protocol 18-N-0066 required
You will not qualify if you...
- Not a surgical candidate for epilepsy
- Significant brain abnormalities such as tumor, stroke, trauma, or blood vessel issues on baseline MRI
- Positive HIV test
- Pregnancy or breastfeeding
- Claustrophobia preventing MRI
- Unable to lie on back for at least two hours
- Risk for MRI scan due to implants, metal objects, or history as metal worker
- Unwilling to share study data for future research
- History of post-ictal psychosis or aggression (for MEMRI arm)
- Planning pregnancy within 2 months (for MEMRI arm)
- Significant liver or kidney disease increasing risk from manganese exposure (for MEMRI arm)
- History of drug or alcohol abuse (AUDIT score 8 or higher) (for MEMRI arm)
- Lab abnormalities over 2 times normal limits (for MEMRI arm)
- Occupational manganese exposure (for MEMRI arm)
- Allergy to manganese (for MEMRI arm)
- Current treatment with calcium-channel blockers (for MEMRI arm)
- Iron-deficiency anemia (for MEMRI arm)
- Personal or family history of Parkinson's disease or Parkinsonism (for MEMRI arm)
- Estimated GFR under 60 within 1 week of scan (for gadolinium MRI arm)
- Allergy to gadolinium (for gadolinium MRI arm)
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Aaliyah M HamidullahThiam
CONTACT
S
Sara K Inati, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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