Neurofrailty: A Study of Late-onset Epilepsy and Its Associations
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLancashire Teaching Hospitals NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
360 Participants
are grouped into 2 trial groupsGroup A: Case (Late-onset epilepsy)
Group B: Control (migraine)
Trial outcomes
Primary outcomes
1
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 years2
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 yearsSecondary outcomes
1
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 years2
Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?
As described
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov