Surgery as a Treatment for Medically Intractable Epilepsy
- Epilepsy
- Epilepsy, Temporal Lobe
- Partial Epilepsy
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Enrolment target
- 300
- Started
- 21 March 2011
- Main results due
- Not stated
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 8 years to 99 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
* INCLUSION CRITERIA: To be eligible for entry into the study, candidates must: 1\. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy. EXCLUSION CRITERIA: Candidates will be excluded if they: 1\. Are unable or unwilling to give informed consent, or have a parent able to provide informed consent if a minor, to the research procedures.
What this study is about
In the sponsor’s own words, from the registry.
Background:
\- Drug resistant 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 using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment.
Objectives:
\- To use surgery as a treatment for drug resistant epilepsy in children and adults.
Eligibility:
\- 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.
Design:
* 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. * Electrodes placed directly in the brain or on the surface of the brain 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.
Study sites(1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT01273129. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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