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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-N-0177

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 60

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

MRI;
Manganese Enhanced MRI;
Seizure Disorder;
Seizures;
Epileptic Focus

Recruitment Keyword(s)

None

Condition(s)

Epilepsy

Investigational Drug(s)

mangafodipir

Investigational Device(s)

None

Intervention(s)

Drug: Mangafodipir

Supporting Site

National Institute of Neurological Disorders and Stroke

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

- Are enrolled in protocol 01-N-0139

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 (not for healthy volunteers)

- 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.

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Eligibility

INCLUSION CRITERIA:

- 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 in NINDS Clinical 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 CRITERIA:

General exclusions:

- History of brain disease other than epilepsy.

- Patients with epilepsy who are not surgical candidates

- Positive test for HIV.

- History of post-ictal psychosis or post-ictal aggression

- Brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on an MRI scan.

- Pregnancy or breast-feeding.

-- Planning to get pregnant in the next 2 months

- 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)

- History of clinically significant medical disorders other than epilepsy, such as 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 outside of the range 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

- Unwilling to allow sharing and/or use in future studies of coded data that are collected for this study

Gadolinium enhanced MRI component specific exclusions (not applicable for patients opting out of this portion of the study):

- Estimated GFR greater than or equal to 60, tested within 1 week of scan

- Allergy to gadolinium


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Aaliyah H. Hamidullah-Thiam
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5680
10 Center Drive
Bethesda, Maryland 20892
(301) 496-5121
aaliyah.hamidullahthiam@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02531880

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