NCT01273129 Surgery as a Treatment for Medically Intractable Epilepsy
| NCT ID | NCT01273129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2011-03-21 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2011-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Kareem A Zaghloul, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT01273129 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 99 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01273129 currently recruiting?
Yes, NCT01273129 is actively recruiting participants. Contact the research team at SNBrecruiting@nih.gov for enrollment information.
Where is the NCT01273129 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT01273129 clinical trial?
NCT01273129 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Kareem A Zaghloul, M.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 300 participants.
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