NCT07116330 Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
| NCT ID | NCT07116330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 420 participants in total. It began in 2025-09-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A growing body of evidence suggests patients with late-onset seizures are at an increased risk of stroke, but the potential for reducing cardiovascular morbidity through risk factor screening and management is unknown. The investigators aim to determine whether individuals with new-onset unprovoked seizures after middle age should undergo vascular risk assessment. In a cluster project the investigators assess the effect of vascular risk factor screening in an observational study as well as a cohort study. The project has two interlinked components: a prospective single group study, in which risk factor assessment is performed and subsequent management is followed for one year; and a register-based cohort study examining the long-term effects of the intervention on a system level.
Eligibility Criteria
Inclusion Criteria Clinical study: \- First assessment for unprovoked seizures or epilepsy with onset after age 50 -- - vascular risk factor evaluation per the new routine at participating care givers Register study: * age ≥50 with a first-ever outpatient appointment to one of the participating clinics and * a first-listed diagnostic code for seizures or epilepsy (ICD-10: R568, G40) Exclusion Criteria Clinical study: * Inability to consent. * Progressive brain disease (tumour or degenerative) Register study: * preexisting seizures/epilepsy, as demonstrated by a registered diagnostic code for seizures (ICD-10: R568, G40, G41) or a dispensed antiseizure medication (ATC-code: N03) more than 3 months before the initial consultation * a registered diagnostic code for stroke or TIA (ICD-10: I61, I63, I64, or G45 except G454) before the initial consultation, or * progressive brain disease, as indicated by diagnostic codes or drug prescriptions suggestive of brain tumors (ICD-10: C71, D33, D43, C793) or * neurocognitive disorders (ICD-10: F00-F03, F051, G30, G318, G912; ATC code: N06D).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07116330 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116330 currently recruiting?
Yes, NCT07116330 is actively recruiting participants. Contact the research team at johan.zelano@neuro.gu.se for enrollment information.
Where is the NCT07116330 trial being conducted?
This trial is being conducted at Borås, Sweden, Gothenburg, Sweden, Malmö, Sweden.
Who is sponsoring the NCT07116330 clinical trial?
NCT07116330 is sponsored by Sahlgrenska University Hospital. The trial plans to enroll 420 participants.
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