Neurofrailty: A Study of Late-onset Epilepsy and Its Associations

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263920
• Other study ID #: 288703
• Status: Recruiting
• Start date: May 5, 2022
• Est. completion date: January 12, 2027

Study information

• Verified date: February 2024
• Source: Lancashire Teaching Hospitals NHS Foundation Trust
• Contact: Jasmine Wall, MB BChir
• Phone: via switchboard
• Email: jasmine.wall[@]lthtr.nhs.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

We don't know a great deal about why some people develop seizures in adulthood, but some researchers think that it might tell us something about 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 we don't 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. Through the NeuroFrailty study, we will observe 'brain health' over the years following the onset of a seizure, and I hope that it might give us more information about people with these kinds of seizures.

The NeuroFrailty study involves observing people from the time of diagnosis of first seizure. At this time, we will look at investigations such as blood tests, blood pressure, brain scans, alongside other diagnoses which might tell us whether there are differences compared to people without seizures. For some people, we will also look in greater depth at lifestyle including exercise, driving, family planning, and memory assessments.

Over the following years, we will look at how things change: 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. You will receive a yearly newsletter to keep you updated on everything we learn about late-onset epilepsy.

Purpose and Background

Most of the time, we do not know why an adult develops epilepsy. 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, so we cannot say whether this is true.

What does taking part involve?

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. I will not have access to more detailed information, such as conversations between a participant and their GP.

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.

If someone decides in the future that they don't want to be involved, they can withdraw from the study. However, once the study is completely finished, the information will be completely anonymous, which means that I won't be able to find individual's information in order to delete it.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: January 12, 2027
• Est. primary completion date: January 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Epilepsy
• Stroke

Locations

Country	Name	City	State
United Kingdom	Lancashire Teaching Hospitals NHS	Preston	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population?	Including HbA1c, hypertension / blood pressure, total cholesterol, triglycerides, MRI changes	3 years
Primary	Quality of Life - how of chronic illness is mediated	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	3 years
Secondary	What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population?	As described	3-5 years
Secondary	Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?	As described	3 years