Why People with Epilepsy Get More Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will follow a cohort of about 500 participants, including new and established epilepsy patients as well as individuals with first seizures and migraines, for up to 10 years to explore links between antiseizure medications, immune parameters, and infection rates. It will use routine healthcare data to build predictive models for infection risk and to help understand possible mechanisms of immune dysfunction related to common antiseizure drugs. The project aims to distinguish effects due to epilepsy itself from those due to medications by comparing treated and untreated groups. Recruitment is centered in NHS Grampian, with University of Aberdeen as the lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Applied Health Sciences, University of Aberdeen
  Aberdeen, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.