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

Erasmus Medical Center, Rotterdam, The Netherlands0 个研究点目标入组 55 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

ot applicable

•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.

•- 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.

发起方

Erasmus Medical Center, Rotterdam, The Netherlands