Badanie przepuszczalności bariery mózgowo-krwionośnej za pomocą rezonansu magnetycznego ze składnikiem manganowym u pacjentów z epilepsją oporną na leki
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
W skrócie
Badanie sprawdza, czy nowa substancja (mangafodipir) podawana podczas badania MRI może bezpiecznie pokazać na obrazach części mózgu uszkodzone przez epilepsję oporną na leki. Pacjenci w wieku 18-60 lat, u których leki nie kontrolują drgawek, będą mieć do 6 wizyt w ciągu 1-3 miesięcy, w tym kilkudniowy pobyt w szpitalu z monitorowaniem mózgu, wstrzyknięciem substancji do żyły i wykonaniem pięciu badań MRI mózgu.
Oryginalny opis (angielski)
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....