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

NCT06263920 | Recruiting

• 1 other identifier: 288703
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Late Onset Epilepsy; Stroke; Dementia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Lancashire Teaching Hospitals NHS

Preston, Lancashire, PR2 9HT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Stroke; Dementia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jasmine Wall, MB BChir

  University of Lancaster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine Wall, MB BChir

CONTACT

via switchboard; jasmine.wall@lthtr.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: May 5, 2022
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

GB (1)