Surgery as a Treatment for Medically Intractable Epilepsy
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| ClinicalTrials.gov Identifier: NCT01273129 |
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Recruitment Status :
Recruiting
First Posted : January 10, 2011
Last Update Posted : May 12, 2023
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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.
| Condition or disease |
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| Epilepsy Epilepsy, Temporal Lobe Partial Epilepsy |
Show detailed description
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Surgery as a Treatment for Medically Intractable Epilepsy |
| Actual Study Start Date : | March 21, 2011 |
| Group/Cohort |
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Patients
Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study as well as patients with tumor related epilepsy in whom invasive monitoring is indicated.
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- Descriptive and/or correlational studies [ Time Frame: 1 year ]By providing standard care treatment for patients with drug resistant epilepsy, this protocol allows for descriptive and/or correlational studies based on the data collected through clinical care of these patients including neurophysiological correlates of cognitive function and studies of tissue sample acquired during surgery. Outcomes for patients with tumor related epilepsy will be assessed under a separate protocol, 16-N-0041, Tumor Related Epilepsy.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 8 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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 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.
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: Gretchen C Scott, R.N. | Not Listed | SNBrecruiting@nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | 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 TTY dial 711 ccopr@nih.gov | |
| Principal Investigator: | Kareem A Zaghloul, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT01273129 |
| Other Study ID Numbers: |
110051 11-N-0051 |
| First Posted: | January 10, 2011 Key Record Dates |
| Last Update Posted: | May 12, 2023 |
| Last Verified: | November 15, 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | .We do plan to share IPD. we will share all IPD that results in a publication on a public repository, as required by most journals. the data will be de-identified and anonymized. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neurosurgery Childhood Epilepsy Epilepsy |
Frontal Lobe Epilepsy Temporal Lobe Epilepsy Natural History |
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Epilepsy Epilepsies, Partial Drug Resistant Epilepsy Epilepsy, Temporal Lobe |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Epileptic Syndromes |