NCT06263920|Recruiting
Neurofrailty: A Study of Late-onset Epilepsy and Its Associations
A Prospective Population-based Longitudinal Observational Cohort Study of Late-onset Epilepsy, and Subsequent Stroke and Dementia.
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A Prospective Population-based Longitudinal Observational Cohort Study of Late-onset Epilepsy, and Subsequent Stroke and Dementia.
Sponsor study identifier
observational
360
1 country
1
Study Start
May 5, 2022
Actual (reported)Primary Completion
January 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2022
Actual (reported)February 9, 2024
Actual (reported)February 16, 2024
Actual (reported)January 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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
Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?
3 years
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.
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.
Lancashire Teaching Hospitals NHS
Preston, Lancashire, PR2 9HT, United Kingdom
Blood samples
Jasmine Wall, MB BChir
University of Lancaster
First Submitted
February 9, 2024
First Posted
February 16, 2024
Study Start
May 5, 2022
Actual (reported)Primary Completion
January 12, 2027
EstimatedPreliminary Randomised Evaluation of Singing in Dementia
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 8, 2025
Record last verified: 2025-04
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