Immunotherapy in Autoimmune Encephalitis

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is to explore the treatment effects and long-term prognosis (12 months and 24 months after immunotherapy) by comparing the early plasma exchange (PE) combined with medication therapy with the PE after medication immunotherapy in autoimmune encephalitis (AE) patients, to make clear that the early PE can be more effective than the treatment of PE after medication immunotherapy. As well as, the study is to explore whether PE is also effective in AE with autoantibody synthesis in the sheath, positive cerebrospinal fluid antibody and seronegative.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yan Zhang
• Treatments: Antibodies; Glucocorticoids; Immunoglobulins

Criteria

Inclusion Criteria:

• Diagnosis can be made when all four* of the following criteria have been met:

1. Subacute onset (rapid progression of less than 3 months) of working memory deficits,seizures, or psychiatric symptoms suggesting involvement of the limbic system

2. Bilateral brain abnormalities on T2-weighted fl uid-attenuated inversion recovery MRI highly restricted to the medial temporal lobes†

3. At least one of the following:

• CSF pleocytosis (white blood cell count of more than fi ve cells per mm3)

• EEG with epileptic or slow-wave activity involving the temporal lobes

4. Reasonable exclusion of alternative causes

Exclusion Criteria:

• 1. Serious underlying diseases, such as severe active hemorrhage, disseminated intravascular coagulation, severe hypotension or shock, unstable cardiac failure, cerebral hernia, severe infection, severe abnormal mental behaviors and other endangered conditions.

• 2. Previous history of IVIG allergy.

• 3. Severe nerve dysfunction (mRS>3) before the onset.