Efficacy of Tacrolimus and I.V.-Immunoglobulins in Rasmussen Encephalitis
Status:
Unknown status
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Rasmussen encephalitis (RE) is a rare but severe chronic inflammatory brain disease of
unknown origin affecting one brain hemisphere. It is usually accompanied by intractable
epilepsy. In addition, it often leads to severe disability due to functional deficits caused
by atrophy of one brain hemisphere. Hemispherectomy is an effective means of surgical
treatment of the epilepsy. It renders the patient, however, hemiplegic, hemianopic and (if
the language dominant hemisphere is affected) aphasic. To slow down or even stop the
progressive inflammatory damage to the affected brain hemisphere, immunotherapies may be
beneficial. According to a literature survey, tacrolimus (twice daily intake of capsules) and
intravenous immunoglobulins (monthly infusions) are the most promising compounds for this. In
the investigators' study, these two types of treatment are randomly assigned to patients with
disease onset within the last year and not too far advanced disability or hemispheric brain
injury. The patients are followed to assess prospectively the functional and brain MRI course
of the disease.