Bethesda, MDNCT02531880Now EnrollingIRB Ready

Epilepsy Clinical Trial in Bethesda, MD

Access cutting-edge epilepsy treatment through this phase 1 clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

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Expert Care in Bethesda

Access epilepsy specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related epilepsy treatment provided free

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Check if you qualify for this epilepsy clinical trial in Bethesda, MD

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Epilepsy Study in Bethesda

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 magnetic resonance imaging (MRI) using either mangafodipir or gadolinium can show areas of blood-brain barrier breakdown in people with epilepsy. 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. One visit is 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. * Getting gadolinium through the IV. * Up to 6 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.

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Who Can Participate

Inclusion Criteria

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 Criteria

General exclusions:
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 MEMRI component specific exclusions (applicable only to patients participating in this arm of the 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 Gadolinium enhanced MRI component specific exclusions (applicable only to patients participating in this arm of the study):
Estimated GFR \<60, tested within 1 week of scan
Allergy to gadolinium Of note, patients who are ineligible for one arm of the study may still be eligible for and participate in the other arm of the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT02531880) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Epilepsy Treatment Options in Bethesda, MD

If you're searching for epilepsy treatment options in Bethesda, MD, this clinical trial (NCT02531880) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced epilepsy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all epilepsy clinical trials near you to find additional studies recruiting in your area.

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