Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT06263920
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2024-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurofrailty: A Study of Late-onset Epilepsy and Its Associations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'targetDuration': '60 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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?', 'timeFrame': '3 years', 'description': 'Including HbA1c, hypertension / blood pressure, total cholesterol, triglycerides, MRI changes'}, {'measure': 'Quality of Life - how of chronic illness is mediated', 'timeFrame': '3 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population?', 'timeFrame': '3-5 years', 'description': 'As described'}, {'measure': 'Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated?', 'timeFrame': '3 years', 'description': 'As described'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Late Onset Epilepsy', 'Stroke', 'Dementia']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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.\n\nPurpose and Background\n\nSome 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.\n\nThis 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.\n\nParticipants can choose the level of involvement that is right for them.\n\n1. 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.\n2. 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.\n3. 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.\n\nGlossary 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.\n\nNeurofrailty = A condition whereby a person is at risk of stroke or dementia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nControl 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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria for case participants includes:\n\n* diagnosis of LOE or first seizure after the age of 18.\n* diagnosis confirmed or established at a tertiary neurology centre.\n* 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.\n\nInclusion criteria for control participants includes:\n\n* established diagnosis of migraine.\n* with or without therapeutic medications with antiepileptic properties.\n\nExclusion Criteria\n\nExclusion criteria for case participants includes:\n\n* 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.\n* 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.\n\nExclusion criteria for control participants includes:\n\n* diagnosis of epilepsy or confirmed seizure.\n* 'lesional' attributable cause for seizures including malignancy, stroke (excluding transient ischaemic attack), hypoxic brain injury, trauma."}, 'identificationModule': {'nctId': 'NCT06263920', 'briefTitle': 'Neurofrailty: A Study of Late-onset Epilepsy and Its Associations', 'organization': {'class': 'OTHER', 'fullName': 'Lancashire Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'A Prospective Population-based Longitudinal Observational Cohort Study of Late-onset Epilepsy, and Subsequent Stroke and Dementia.', 'orgStudyIdInfo': {'id': '288703'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case (Late-onset epilepsy)', 'description': "Observational study - no intervention. Participants with first seizure or new diagnosis of epilepsy, in adulthood.\n\nInclusion criteria for cases includes:\n\n* diagnosis of LOE or first seizure after the age of 18.\n* diagnosis confirmed or established at a tertiary neurology centre.\n* 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.\n\nExclusion criteria for cases includes:\n\n* 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.\n* 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."}, {'label': 'Control (migraine)', 'description': "Inclusion criteria for controls includes:\n\n* established diagnosis of migraine.\n* with or without therapeutic medications with antiepileptic properties.\n\nExclusion criteria for controls includes:\n\n* diagnosis of epilepsy or confirmed seizure.\n* 'lesional' attributable cause for seizures including malignancy, stroke (excluding transient ischaemic attack), hypoxic brain injury, trauma.\n\nHowever, 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."}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PR2 9HT', 'city': 'Preston', 'state': 'Lancashire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Kina Bennett', 'role': 'CONTACT', 'email': 'kina.bennett@lthtr.nhs.uk', 'phone': '(+44) 01772 522031'}, {'name': 'Research Access', 'role': 'CONTACT', 'email': 'research.access@lthtr.nhs.uk'}, {'name': 'Jasmine Wall', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lancashire Teaching Hospitals NHS', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'centralContacts': [{'name': 'Jasmine Wall, MB BChir', 'role': 'CONTACT', 'email': 'jasmine.wall@lthtr.nhs.uk', 'phone': 'via switchboard'}], 'overallOfficials': [{'name': 'Jasmine Wall, MB BChir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lancaster'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lancashire Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}