Why Do People With Epilepsy Get More Infections?
Epilepsy · Antiepileptic Drugs · Infection · Immune Dysfunction
De qué trata este estudio
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- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 16 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No informado
- Participantes
- 500 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
People with epilepsy are predisposed to having seizures ("fits"), where abnormal electrical activity in the brain disrupts normal brain functioning. It is a common condition with around 1% of the population of Scotland having this condition. They are treated with anti-seizure medications, drugs which reduce the chance of having seizures.
Unfortunately, people with epilepsy are more likely to have severe infections than those without epilepsy and this is known to increase risk of seizures. The reasons for more severe infections in people with epilepsy are unclear, but one factor may be that anti-seizure medications impair the function of the body's immune system, which fights infection. The investigators' previous work looking at residents in the North-East of Scotland showed a link between these medications and risk of infection.
The investigators plan to study people being started on antiseizure medications (ASMs) with a new diagnosis of epilepsy and those already on ASMs with an established diagnosis of epilepsy in NHS Grampian. The investigators will compare with people not taking ASMs in a group of people with a single seizure and in a group of people with migraine.
The investigators will investigate immune function and infection risk with more-detailed information about individual's background, their seizures/epilepsy, other health conditions, and blood tests. The investigators will then do laboratory experiments to determine how ASMs may impair the immune system by looking at the function of types of white blood cells that play an important part in immune functioning.
The investigators also wish to develop statistical tools which can identify an individual's risk of infection when starting ASMs, based on their demographic, medical and social characteristics, to target closer monitoring/changes in treatment to those with higher risk.
This research will allow healthcare professionals to provide better individualised care in terms of which medication to use for treatment, what doses to use and whether blood tests to screen for impaired immune function would be helpful. The aim is that this will lead to reduced risk of infections in people with epilepsy, resulting in better outcomes in this condition.
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Background:
Epilepsy is a common neurological condition affecting 1% of the population and is associated with a 2.6-fold increased mortality risk, partly due to infection-related deaths. The investigators previously showed that anti-seizure medications (ASMs) are associated with abnormal immune function (hypogammaglobulinemia, lymphopenia, and neutropenia) and increased infection risk, but further work is needed to understand this risk and whether it can be reduced.
Aims:
1. To clarify the effects of ASM on blood immune parameters
2. To establish whether ASMs are associated with increased infection rates
3. To explore potential mechanisms of immune dysfunction with commonly used ASMs
4. To develop predictive models for infection risk based on clinical and laboratory data
5. To develop and validate algorithms using routinely collected healthcare data to determine diagnosis of epilepsy, recurrence of seizure and good seizure control.
Protocol/methodology:
The investigators will recruit a cohort of approximately 500 participants: 100 new epilepsy cases and 100 established epilepsy cases (treated with ASMs) and 200-300 first seizures and 0-100 people with migraine (not treated with ASMs) and follow them for 10 years. This will result in an initial cohort of approximately 200 individuals treated with ASMs (new and established epilepsy) and 300 not treated with ASMs (between first seizure and migraine). Using this cohort, the investigators will investigate changes in immune parameters (hypogammaglobulinemia, lymphopenia, neutropenia) in people treated with ASMs. The investigators will then investigate the frequency of infections. These analyses will expand on the investigators' previous work by adjusting for co-morbidities and studying specific types of infection, such as opportunistic infections. The investigators will use routinely collected data to support the information gathered from patients during the study, and to validate the use of this for determining diagnosis of epilepsy and seizure frequency.
The investigators will investigate potential mechanisms of immune system dysfunction with ASMs with in vitro studies of innate immune system activity, including phagocytosis assays, killing assays, and viability assays in cultured macrophages/neutrophils with and without ASMs
The investigators will then develop a prognostic model to identify people taking ASMs who are at high risk of infection who may need monitoring of immune parameters.
Expected outcomes/benefits:
1. A better understanding of infection risk in those treated with ASMs.
2. Ability to identify those at high infection risk and intervene to reduce infection-related morbidity/mortality with screening, changing ASMs, or interventions directed at the mechanisms.
¿Quién podría participar?
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Inclusion Criteria:
1. Adults aged 16 or over
2. Resident in an area covered by NHS Grampian neurology service
3. Individuals with:
1. A diagnosis of first unprovoked (or reflex) seizure; or
2. A new diagnosis of epilepsy (at least two unprovoked (or reflex) seizures occurring more than 24 hours apart)); or
3. Established diagnosis of epilepsy; or
4. A diagnosis of migraine
4. Able to give informed consent to participate or, if lacking capacity, a reliable Welfare Guardian/Welfare Attorney/Nearest Relative can give consent on behalf of the participant.
Definition of established epilepsy in this context:
1. The individual was diagnosed with epilepsy prior to the consultation at which the clinician referred them to the research team; or
2. When a potential participant is identified from a previous clinic consultation, they already have a diagnosis of epilepsy.
Exclusion Criteria:
1. Functional (non-epileptic) seizures without epileptic seizures or migraine. If the patient has both epileptic and functional seizures, or migraine and functional seizures, they would be eligible for inclusion, provided they meet the other criteria.
2. Acute symptomatic seizure(s) without previous or subsequent unprovoked seizure(s) (e.g. due to head trauma, severe infection, significant electrolyte abnormality, alcohol withdrawal) would be an exclusion from the first seizure/epilepsy group.
3. First seizure group:
a) Those taking or are planned to be started on antiseizure medication(s)
4. New diagnosis of epilepsy group:
1. Those not planned to be started on an antiseizure medication
2. Those taking, or are planned to be started on, two or more antiseizure medications
3. Those already taking an antiseizure medication at the time of their new diagnosis of epilepsy
5. Established epilepsy group:
1. Those taking, or are planned to be started on, two or more antiseizure medications
2. Those not taking an antiseizure medication, even if planned to be started on an antiseizure medication
6. Migraine control group:
1. Receiving treatment with antiseizure medications; or
2. Receiving immunosuppressive\* treatment for another condition; or
3. Medical history of single unprovoked seizure or epilepsy
- Exclusion due to immunosuppression increasing risk of immune dysfunction. Immunosuppression is not an exclusion criterion for first seizure/epilepsy groups as immunosuppression will be used as a variable for other analyses, including risk prediction analyses.
Población del estudio
Resident in an area covered by NHS Grampian neurology service.
Potential participants will have either been reviewed by the neurology team as an inpatient or outpatient.
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- No informado
- Enmascaramiento
- No informado
Exposed
Individuals taking antiseizure medications
Drug: Antiepileptic Drug
Unexposed
Individuals not taking antiseizure medications
Antiepileptic Drug DRUG
Antiseizure medications prescribed as routine care
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Infections
Plazo: During a 10 year period from the time of enrolment
Clinically significant rates of infection (community antimicrobial prescriptions or hospital admissions with infection)
Medidas secundarias
Blood immune system parameters
Plazo: During a 10 year period from the time of enrolment
Abnormal level of blood immune system parameters (white blood cell counts, immunoglobulins, lymphocyte subsets)
Experimental laboratory tests
Plazo: Blood obtained during enrolment and/or 6 months after enrolment
In vitro macrophage and/or neutrophil functioning with exposure to common ASMs (carbamazepine, lamotrigine, levetiracetam, phenytoin, sodium valproate)
Prediction of infection
Plazo: During a 10 year period from the time of enrolment
A prognostic model (a statistical tool) that can be used to predict infection frequency in those being started on ASMs.
Validated algorithm
Plazo: During a 10 year period from the time of enrolment
Validated algorithms using routinely collected healthcare data to i) identify diagnoses of epilepsy; ii) measure seizure recurrence and iii) good seizure control.
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Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Institute of Applied Health Sciences, University of AberdeenAberdeen, United KingdomReclutando
Equipo y fechas
- Patrocinador principal
- University of Aberdeen
- Inicio del estudio
- 4 nov 2026 Real
- Finalización primaria
- 2038-05 Estimado
- Finalización del estudio
- 2038-05 Estimado
- Primera publicación
- 29 oct 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Epilepsy, Immune Dysfunction and Risk of Infection Study - A Prospective Cohort Study of Immune Dysfunction and Infection Risk With Epilepsy
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026