An observational study in Late Onset Epilepsy, Stroke and Dementia, sponsored by Lancashire Teaching Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Lancashire Teaching Hospitals NHS Foundation Trust · Observational
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.
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 360 is above the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →Lancashire Teaching Hospitals NHS Foundation Trust is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion criteria for case participants includes:
Inclusion criteria for control participants includes:
Exclusion Criteria
Exclusion criteria for case participants includes:
Exclusion criteria for control participants includes:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Time frame: 3 years
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
Time frame: 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?
As described
Time frame: 3-5 years
Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?
As described
Time frame: 3 years
Plan to share: Undecided — Requests to share the full, anonymised dataset where made by an external investigator who is part of a formal research group with the appropriate expertise such as a statistician, will be reviewed.
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Jan 2027, 56 months after the start.
Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 56 months is above that.
Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
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Lancashire Teaching Hospitals NHS Foundation Trust