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临床试验/NCT01663545
NCT01663545已完成不适用

Positron Emission Tomography Measurement of Neuroinflammation in Focal Epilepsy

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Amount of differential [11C]dLop and [11C]PBR28 uptake between the epileptic focus and the homologous contralateral region

研究概览

简要总结

Background:

  • The brain is protected by a barrier that keeps toxins in the blood from reaching the brain. However, this barrier can also keep useful medications from reaching the brain. P-glycoprotein (P-gp) is a brain protein that is part of the blood-brain barrier. The level of P-gp is higher in people with epilepsy than in people without epilepsy. These different levels of P-gp may explain why some people have seizures that do not respond well to medications. Researchers want to see if P-gp can affect the response to epilepsy medications.
  • Epilepsy may also be associated with brain inflammation. Researchers also want to look at the part of the brain affected by epilepsy to see if inflammation is present.

Objectives:

  • To see if P-gp can affect the response to epilepsy medications.
  • To see if inflammation is present in the part of the brain affected by epilepsy.

Eligibility:

  • <TAB>Individuals between 18 and 60 years of age who have temporal lobe epilepsy. We plan to study some patients whose seizures are well controlled by drugs, and some whose seizures are not controlled.
  • <TAB>
  • Healthy volunteers between 18 and 60 years of age.

Design:

  • This study requires four or five visits to the NIH Clinical Center over the course of a year. The visits will be outpatient visits and will last from 2 to 5 hours.
  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
  • All participants will have two positron emission tomography (PET) scans. The scans will take place during different visits. Different drugs will be used in each scan. One drug will be used to temporarily block the effect of P-gp in the brain. The other drug will show areas of inflammation in the brain.
  • Participants with epilepsy will have a third PET scan. This scan will also look at P-gp activity in the brain. However, it will not use the drug that blocks the effect of P-gp.
  • All participants will also have one magnetic resonance imaging scan. This scan will help show brain function.

详细描述

Objectives:

  1. To study the role of inflammation in focal epilepsy
  2. To characterize the BBB state in patients with focal epilepsy using MRI, and compare the results with PET imaging of inflammation
  3. To study test-retest replicability of [11C]PBR28 PET scanning.

Study population:

50 participants with drug-resistant focal epilepsy, 25 participants with drug-responsive focal epilepsy and 25 healthy volunteers.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Amount of differential [11C]dLop and [11C]PBR28 uptake between the epileptic focus and the homologous contralateral region

时间窗: study completion

次要结局

  • Secondary Outcome Measure: A secondary goal is to determine if inhibiting P-gp with tariquidar results in increased concentrations of anti-epileptic medications into the CSF, as a surrogate marker for increased penetration of these medication...(study completion)

研究者

研究点 (1)

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