Late Onset EpilepsyNCT06263920
Neurofrailty: A Study of Late-onset Epilepsy and Its Associations
An observational study of Late Onset Epilepsy and Stroke, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Late Onset Epilepsy, Stroke, Dementia
- How many people
- 360 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2022to 12 Jan 2027
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Lancashire Teaching Hospitals NHS
Preston, Lancashire, PR2 9HT
Kina Bennett, (+44) 01772 522031, kina.bennett@lthtr.nhs.uk
Research Access, research.access@lthtr.nhs.uk
About this study
Official title: A Prospective Population-based Longitudinal Observational Cohort Study of Late-onset Epilepsy, and Subsequent Stroke and Dementia.
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.
Read the 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.
- 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.
- 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.
- 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
- Medical subject headings
- Stroke, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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?
As described
Measured: 3-5 years
Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?
As described
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start5 May 2022
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Onset EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmine Wall, MB BChir, Principal investigator, University of Lancaster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263920
- Sponsor's protocol ID
- 288703
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Population-based Longitudinal Observational Cohort Study of Late-onset Epilepsy, and Subsequent Stroke and Dementia.
- ClinicalTrials.gov ID
- NCT06263920
- Acronym / sponsor ID
- 288703
- Conditions
- Late Onset Epilepsy, Stroke, Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 12 Jan 2027 (estimated)
- Study completion
- 12 Jan 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population?
Time frame: 3 years
Including HbA1c, hypertension / blood pressure, total cholesterol, triglycerides, MRI changes
Quality of Life - how of chronic illness is mediated
Time frame: 3 years
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
2 secondary outcomes
What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population?
Time frame: 3-5 years
Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: 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.
Related trials for Late Onset Epilepsy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
Epilepsy, Seizure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasmine Wall, MB BChir principal investigator
University of Lancaster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Late Onset Epilepsy and Stroke, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Wall, MB BChir (via switchboard, jasmine.wall@lthtr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population? (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.