The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

Medically-intractable or uncontrolled epilepsy is a type of epilepsy that cannot be controlled with medication. Some people whose seizures do not respond to medication may respond to surgery. The purpose of this study (11-N-0051) is to learn more about medically-intractable or uncontrolled epilepsy and its treatment. Standard epilepsy treatment, including the possibility of surgery if needed, will be provided to participants.

Volunteers must be 8 years of age or older and will be evaluated with standard epilepsy testing under research study 01-N-0139 (Evaluation and Treatment of Patients with Epilepsy), including magnetic resonance imaging (MRI) of the brain, blood tests, video electroencephalography, and neurological examinations. Participants will be admitted to the NIH Clinical Center for about 2 weeks for testing and possible surgery and recovery. Surgery offered under this protocol would be implantation of subdural electrodes and depth electrodes for monitoring of seizure activity, and possible surgical resection of seizure focus. All surgery participants will return for an outpatient visit 3 months after surgery. Participants who have resection of seizure focus will also return for outpatient visits at 12 and 24 months. If surgery is not performed, no further follow-up will be required after the initial 2-week hospital stay. There is no charge for study-related tests and procedures; some travel costs may be reimbursed. Minors must have permission from their parent before participating.

Eligibility Criteria:

INCLUSION CRITERIA: To be eligible for entry into the study, candidates must meet all the following criteria:

  1. Be 8 years of age or older with medically intractable epilepsy or tumor related epilepsy.
  2. Have simple or complex partial seizures.
  3. Seizures must persist despite medical therapy (medically intractable epilepsy) or seizures must be associated with the presence of a brain tumor.
  4. Able to give informed consent, or have a parent able to provide informed consent if a child.
  5. Agree to undergo brain surgery if indicated to treat medically intractable epilepsy.

 

EXCLUSION CRITERIA: Candidates will be excluded if they:

  1. Are pregnant (women 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).
  2. Cannot have an MRI scan.
  3. 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.

Study Design:

Time Perspective: Prospective

Study Location:

Maryland