Clinical trial NCT06263920: Neurofrailty: A Study of Late-onset Epilepsy and Its Associations
Official title: A Prospective Population-based Longitudinal Observational Cohort Study of Late-onset Epilepsy, and Subsequent Stroke and Dementia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Late Onset Epilepsy
Stroke
Dementia
Lead sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case participants will be identified through consecutive adult cases of first seizure or new diagnosis of epilepsy without a 'lesional' cause identified in the regional area served by Preston tertiary neurology centre.

Control participants will be identified through consecutive adult cases of migraine without a 'lesional' cause, identified in the regional area served by Preston tertiary neurology centre.

Brief summary: 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.

Detailed description: 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.

Participants can choose the level of involvement that is right for them.

1. LOW involvement. A researcher will check hospital and General Practice (GP records) once or twice per year, for the limited and specific purpose of checking: medications, any new diagnoses, investigations associated with stroke risk (such as cholesterol, blood pressure, heart trace) and any brain scans that have been performed.
2. HIGH involvement. This involves being contacted by telephone once per year for 15-30 minutes to ask questions assessing memory and enquiring about lifestyle, such as exercise, smoking and alcohol use.
3. VERY HIGH involvement. These participants will be contacted for a longer telephone conversation 30-45 minutes once per year about their experience of how epilepsy has affected home life, work and medications.

Glossary Seizure disorder = any disorder which involved having experienced at least one seizure. First seizure and epilepsy both can be classed as a form of seizure disorder.

Neurofrailty = A condition whereby a person is at risk of stroke or dementia.

Eligibility criteria: Inclusion criteria for case participants includes:

* diagnosis of LOE or first seizure after the age of 18.
* diagnosis confirmed or established at a tertiary neurology centre.
* sequential cases will be used; in the unlikely event that eligible cases outstrip capacity, an annual cap of the first 150 patients per year per cohort will be used.

Inclusion criteria for control participants includes:

* established diagnosis of migraine.
* with or without therapeutic medications with antiepileptic properties.

Exclusion Criteria

Exclusion criteria for case participants includes:

* a 'lesional' attributable cause for seizures including malignancy, stroke (excluding transient ischaemic attack), hypoxic brain injury, trauma, vascular or congenital abnormality of likely aetiological significance.
* people with migraine or headache syndrome can be included in case group - the presence or absence of a seizure syndrome is mutually exclusive between case and control groups, not the presence or absence of migraine.

Exclusion criteria for control participants includes:

* diagnosis of epilepsy or confirmed seizure.
* 'lesional' attributable cause for seizures including malignancy, stroke (excluding transient ischaemic attack), hypoxic brain injury, trauma.

Primary outcomes:
measure: At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population?
timeFrame: 3 years
measure: Quality of Life - how of chronic illness is mediated
timeFrame: 3 years
Secondary outcomes:
measure: What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population?
timeFrame: 3-5 years
measure: Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?
timeFrame: 3 years
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS
state: Lancashire
Study officials:
affiliation: University of Lancaster
name: Jasmine Wall, MB BChir
role: PRINCIPAL_INVESTIGATOR
References: