Autoimmune epilepsy Modulated by IVIg – effects on Cortical Excitability, the AMICE study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 55

Inclusion Criteria

Age of 18 years and older.
- Epilepsy, with at least one seizure per week at baseline.
- Antibodies proven in serum and/or CSF in cell-based assay and/or ELISA and on immunohistochemistry. In case of anti-GAD antibodies, antibody titer with ELISA has to be >10,000 IU in serum or >100 IU in CSF.

Exclusion Criteria

- Age below 18 years.
- Another identified cause of epilepsy (i.e. viral/bacterial encephalitis, stroke, tumor).
- Severe encephalitis in which escalation of therapy (second-line immunotherapy, i.e. Rituximab or Cyclophosphamide) is expected within the study period (mainly anti-NMDAR encephalitis with mRS 5, at the ICU).
- Use of immunotherapy < 3 months ago.
- Use of monoclonal antibodies < 1 year ago.
- Premorbid mRS =3.
- Known hypersensitivity to Privigen or contraindication for Privigen, i.e. IgA deficiency.
- Patient and/or legal representative is withholding informed consent.
- Patient objects after initial informed consent.

A potential subject who meets none of the above mentioned exclusion criteria, but meets one or more of the following exclusion criteria for TMS-EEG, will be excluded from TMS-EEG, but not from the rest of the study:
- Incapacitation of the patient.
- Cochlear implants, implanted neurostimulator or metal in the brain or skull.
- Previous skull opening or trauma.
- Cardiac pacemaker or intracardiac lines.
- Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a seizure frequency reduction >50% and the proportion of patients that achieve full freedom of seizures in week 6, 7 and 8, for all patients with autoimmune epilepsy and compared by subgroup (adjusted for the baseline frequency).

Secondary Outcome Measures