Investigating Epilepsy: Screening and Evaluation
概览
- 阶段
- 不适用
- 干预措施
- Single Arm
- 疾病 / 适应症
- Seizures
- 发起方
- National Institute of Neurological Disorders and Stroke (NINDS)
- 入组人数
- 1000
- 试验地点
- 1
- 主要终点
- Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols
- 状态
- 招募中
- 最后更新
- 26天前
概览
简要总结
Background:
Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy.
Objectives:
To learn more about seizures and find ways to best treat people with drug-resistant epilepsy.
Eligibility:
Adults and children ages 8 years and older with diagnosed or suspected epilepsy
Design:
Participants will be screened with:
Physical exam
Medical history
Questionnaires
Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed.
Participants will have many tests:
Blood and urine tests
EEG: Wires attached to the head with paste record brain waves. This may be videotaped.
Thinking and memory tests
MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube.
MEG: Participants lie on a table and place their head in a helmet to record brain waves.
PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle.
Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.
详细描述
Study Description:\<TAB\> This protocol is designed to serve as a screening protocol that provides standard evaluation and treatment for patients with epilepsy. Clinical data collected through this protocol will be used in other NIH epilepsy-related research to screen for eligibility in the respective protocols and may also be used for descriptive and/or correlative research through this protocol. Objectives: Primary Objective: Maintain a cohort of patients who are referred to the NIH with a known or suspected diagnosis of epilepsy that can be accessed by other NIH studies to screen for eligibility to participate in ongoing epilepsy-related protocols. Secondary Objectives: * to follow the natural history of subjects with epilepsy and epilepsy and related disorders, and * to allow for descriptive and/or correlational studies based on the data collected through clinical care of these patients.
研究者
入排标准
入选标准
- •INCLUSION CRITERIA:
- •Age 8 years or older
- •Known or suspected diagnosis of epilepsy
- •Ability to give informed consent or have a legally authorized representative able to give consent (for adults without consent capacity) or parent/guardian able to provide informed consent (for a child)
- •If unable to give informed consent, ability to give assent (for minors 8 and older)
排除标准
- •Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol
- •Patients who are unable to travel to the NIH
研究组 & 干预措施
Single Arm
Single arm open enrollment of patients with standard of care treatment and evaluation
结局指标
主要结局
Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols
时间窗: 5 year period
to characterization of patients epilepsy to determine their eligibility for inclusion in other epilepsy-related protocols.
次要结局
- Data obtained through clinical care will provide descriptive and/or correlative research(5 year period)