In this study, patients with medically intractable epilepsy (epilepsy that can’t be controlled by medication) will receive tests and surgical treatment. The surgery is not experimental – approximately 50%-66.6% of patients will be relieved of seizures – but the study is looking to train more neurosurgeons in epilepsy surgery and understand its treatment.
Patients will be screened by a physician and if they need and qualify for surgery, they will undergo a variety of tests and procedures to determine the surgical approach including video electroencephalography, a Wada test, and depth electrodes. Participants will then have surgery on the site of their seizure focus to remove brain lesions, abnormal blood vessels, tumors, infections, or other brain abnormalities. Participants will then come back for visits and brain imaging studies at 2 months, 1 year, and 2 years after surgery. Investigators are looking for 300 participants for this study.
- Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.
- Have focal onset seizures.
- Seizures must persist despite medical therapy (drug resistant epilepsy) or seizures must be associated with the presence of a brain tumor.
- Able to give informed consent, or have a parent able to provide informed consent if a child.
- Agree to undergo brain surgery if indicated to treat drug resistant epilepsy.
- Are pregnant (subjects of childbearing age will be tested with a urine pregnancy test and will have agreed to avoid being pregnant by practicing a reliable form of contraception or by abstinence from sexual intercourse while undergoing evaluation for epilepsy surgery and for 1 month after epilepsy surgery).
- Cannot have an MRI scan.
- Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions which would make testing or surgery unsafe, such as lung or cardiac disease which would increase the risk of general anesthesia or severe immunodeficiency or systemic cancer not related to a brain lesion.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org
National Institute of Neurological Disorders and Stroke (NINDS)
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