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

NCT ID: NCT06263920

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2027-01-12

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.

Conditions

Late Onset Epilepsy; Stroke; Dementia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control (migraine)

Inclusion criteria for controls includes:

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

Exclusion criteria for controls includes:

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

However, in both cases and controls, people with dementia, alcohol excess, recreational drug use or pre-existing small vessel disease will be included, as excluding these conditions would bias against the inclusion of the population who may benefit from this research and against the inclusion of patients with high risk of small vessel disease.

No interventions assigned to this group

Case (Late-onset epilepsy)

Observational study - no intervention. Participants with first seizure or new diagnosis of epilepsy, in adulthood.

Inclusion criteria for cases 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.

Exclusion criteria for cases includes:

• another '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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

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

Exclusion Criteria

• 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lancashire Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasmine Wall, MB BChir

Role: PRINCIPAL_INVESTIGATOR

University of Lancaster

Locations

Lancashire Teaching Hospitals NHS

Preston, Lancashire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jasmine Wall, MB BChir

Role: CONTACT

jasmine.wall@lthtr.nhs.uk

via switchboard

Facility Contacts

Kina Bennett

Role: primary

kina.bennett@lthtr.nhs.uk

(+44) 01772 522031

Research Access

Role: backup

research.access@lthtr.nhs.uk

Other Identifiers

288703

Identifier Type: -

Identifier Source: org_study_id