Surgery as a Treatment for Medically Intractable Epilepsy
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|ClinicalTrials.gov Identifier: NCT01273129|
Recruitment Status : Recruiting
First Posted : January 10, 2011
Last Update Posted : May 15, 2019
- Medically intractable epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in training more neurologists and neurosurgeons in epilepsy surgery and care in order to better understand epilepsy and its treatment.
- To use surgery as a treatment for medically intractable epilepsy in children and adults.
- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy.
- Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study.
- Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach.
- Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period.
- Wada test to evaluate speech, comprehension, and memory centers of the brain, using a contrast dye to study the blood vessels of the brain and a short-term anesthetic administration procedure to test the effects on areas of speech and memory.
- Depth electrodes and/or brain surface electrodes to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus).
- Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see.
- Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.
|Condition or disease|
|Epilepsy Epilepsy, Temporal Lobe Partial Epilepsy|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Surgery as a Treatment for Medically Intractable Epilepsy|
|Study Start Date :||December 7, 2010|
- Change in seizure frequency [ Time Frame: 1 year ]
- Percentage seizure-free [ Time Frame: 1 year ]
- Mean Engel Class one year after surgery [ Time Frame: 1 year ]
- Percentage with permanent neurological side-effects from surgical treatment [ Time Frame: 1 year ]
- Incidence of serious complications of epileptic seizures [ Time Frame: 1 year ]
- Percentage of patients who are able to be completely withdrawn from anti-epileptic medication; [ Time Frame: 1 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273129
|Contact: Aaliyah H Hamidullah-Thiam||Not Listed||SNBrecruiting@nih.gov|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|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 email@example.com|
|Principal Investigator:||Kareem A Zaghloul, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|