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临床试验/NCT06263920
NCT06263920招募中不适用

A Prospective Population-based Longitudinal Observational Cohort Study of Late-onset Epilepsy, and Subsequent Stroke and Dementia.

Lancashire Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
1
主要终点
At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population?

研究概览

简要总结

There is not much known about why some people develop seizures in adulthood, but some researchers think that it might be a warning from the body to highlight something may be wrong with the brain. A small number of people with first seizure in adulthood go on to experience problems like stroke or dementia later in life. However, stroke and dementia are common diseases, so it is not know whether there is a real association between these conditions. When people develop their first seizure in adult life, this is sometimes called Late-Onset Epilepsy. The NeuroFrailty study, will observe 'brain health' over the years following the onset of a seizure, to provide more information about people with these kinds of seizures.

详细描述

The NeuroFrailty study involves observing people from the time of diagnosis of first seizure. It will look at investigations such as blood tests, blood pressure, brain scans, alongside other diagnoses to compare difference to people without seizures. The study will also review some participants to look in greater depth at lifestyle including exercise, driving, family planning, and memory assessments.

The study will review how changes occur over a number of years: for example whether there are changes in memory, new diagnoses, medication changes and how lifestyle has changed. Because there is so little research in this area, it is very difficult to predict what might happen. For example, some people can experience worse memory because of medication side effects; on the other hand, good seizure control following a diagnosis can sometimes lead to improved memory. Over years, it may become clear that some diseases are more likely in people with late-onset epilepsy than in people without such a diagnosis.

Purpose and Background

Some researchers think there may be a connection between epilepsy which starts in adulthood, and increased risk of stroke or dementia in the future. However, there is very little research or evidence in this area.

This study is an observational study, which means that the management of participants' seizure disorder will not be affected if they choose to take part in this study. The purpose of this study is to watch participants over the course of several years, to find out more about seizures which start in adulthood.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older 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

At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population?

时间窗: 3 years

Including HbA1c, hypertension / blood pressure, total cholesterol, triglycerides, MRI changes

Quality of Life - how of chronic illness is mediated

时间窗: 3 years

How is the experience of chronic illness in LOE mediated through the immediate experience of seizures (holidays, swimming), socioeconomic factors (unemployment, insurance, driving, family planning) and long-term risk of associated comorbidity

次要结局

  • Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?(3 years)
  • What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population?(3-5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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