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Investigating Blood-Brain Barrier in Drug-Resistant Epilepsy

This study is looking into how the blood-brain barrier (a protective layer around your brain) might be affected in people with drug-resistant epilepsy. Researchers want to see if two different imaging agents, mangafodipir and gadolinium, can help identify areas where this barrier might be disrupted, specifically in the parts of the brain where seizures start. They will use a type of scan called Magnetic Resonance Imaging (MRI) with these agents. The study also aims to understand if mangafodipir is safe for people with epilepsy. You may be able to join if you are 18-60 years old and have epilepsy that isn't controlled by current medications. The study will be considered successful if it can safely show how these imaging agents help identify blood-brain barrier issues in seizure-onset zones.

Study design
This study plans to enroll 40 participants with drug-resistant epilepsy. It is an interventional study, meaning participants will receive specific treatments or interventions.
What's involved
You will undergo screening with a medical history, physical exam, and blood and urine tests. You will have MRI scans, including one with mangafodipir and/or one with gadolinium, and may have long-term video EEG recording as an inpatient.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured after mangafodipir administration, and the utility of the imaging methods will be evaluated after mangafodipir and/or gadolinium administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02531880

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

Recruiting
PHASE1Ages 18–60InterventionalDiagnostic
National Institute of Neurological Disorders and Stroke (NINDS)
~40 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:MangafodipirGadolinium

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
description of the safety profile of mangafodipir administration in patients with epilepsy
Measured over after mangafodipir adminstration
+1 more outcome measured

Conditions

Epilepsy

Explore related trials

Seizure Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Sara K Inati, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)

Who to contact

Aaliyah M HamidullahThiam
[email protected]
(301) 402-7686
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-60.
Able to give written informed consent directly.
Drug resistant epilepsy participants will be defined as having clinically documented seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard anti-seizure treatment for at least one year prior to enrolling in this study and with an average of at least one seizure per month. This criterion will be established by preliminary screening NINDS Epilepsy Service under protocol 18-N-0066. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies. Prior or concurrent enrollment in 18-N-0066 is required.

Exclusion

Patients with epilepsy who are not surgical candidates
Significant structural brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on the baseline MRI scan.
Positive test for HIV
Pregnancy or breast-feeding
Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine.
Cannot lie on their back for at least two hours.
Risk for MRI scan, (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed, or history of being a welder or metal worker due to small metal fragments in the eye)
Unwilling to allow sharing and/or use in future studies of coded data that are collected for this study
History of post-ictal psychosis or post-ictal aggression
Planning to get pregnant in the next 2 months
History of clinically significant liver or kidney disease that could potentially increase the risk of CNS damage due to manganese exposure
A history of drug or alcohol abuse/dependence (subjects scoring 8 or higher on the AUDIT scale)
Screening lab abnormalities demonstrating values more than 2 times the upper limit of normal for AST, ALT, bilirubin, alkaline phosphatase, BUN, creatinine
Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture)
Allergy to manganese
On-going treatment with calcium-channel blocker
Iron-deficiency anemia
Personal history of Parkinson s Disease or Parkinsonism or presence of this disease in a 1st degree relative
Estimated GFR \<60, tested within 1 week of scan
Allergy to gadolinium

What this trial measures

  • description of the safety profile of mangafodipir administration in patients with epilepsyafter mangafodipir adminstration

    safety profile

  • 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.after mangafodipir and/or gadolinium administration

    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.