Surgery as a Treatment for Medically Intractable Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Descriptive and/or correlational studies
研究概览
简要总结
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.
详细描述
Objective
This protocol is being performed to collect prospective data on patients who receive standard of care treatment for drug resistant epilepsy and to follow the natural history of patients receiving epilepsy surgery, to investigate neurophysiological correlates of human cognitive function, to provide invasive monitoring for patients with tumor related epilepsy. Any treatment under this protocol will be based on the current standard of care for epilepsy surgery.
Study Population
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.
Study Design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Descriptive and/or correlational studies
时间窗: 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.
次要结局
未报告次要终点