Autoimmune Encephalitis
Conditions
Interventions
Control group (NMDAR):Slow tapering group (control group): Reduce by 5mg every 14 days.
Intervention group (NMDAR):Rapid tapering group (intervention group): Reduce by 5mg every 7 days.
Control group (LGI1):Slow tapering group (control group): Reduce by 5mg every 14 days.
Intervention group (LGI1):Rapid tapering group (intervention group): Reduce by 5mg every 7 days.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 14–80 years, no gender restrictions; for those under 18 years old, body weight must exceed 40 kg. 2. Acute phase with one or more of the following 8 symptoms: psychiatric or behavioral abnormalities, cognitive impairment, speech disorders, seizures, movement disorders/involuntary movements, decreased level of consciousness, autonomic dysfunction, or central hypoventilation. 3. . Meets the diagnostic criteria for NMDAR or LGI1 autoimmune encephalitis. 4. Received 0.5/1 g * 5 days of methylprednisolone pulse therapy within 2 weeks, has transitioned to oral steroids but has not yet started tapering. 5. For relapsed patients, the modified Rankin Scale (mRS) score prior to this relapse must have recovered to =1 and remained so for at least one year
Exclusion criteria
Exclusion criteria: 1. Contraindications or allergies to glucocorticoids 2. Other diseases requiring steroid treatment 3. Major surgery within the past 3 months 4. Severe uncontrolled infections 5. Severe cardiac, hepatic, or renal insufficiency 6. Body weight over 100 kg 7. Participation in other therapeutic trials 8. Positive intracellular antigen antibodies: anti-Hu, anti-Yo, anti-Ma2, anti-CV2/CRMP-5, anti-GAD65, anti-amphiphysin 9. Diagnosed central or peripheral nervous system demyelinating diseases (e.g., multiple sclerosis, neuromyelitis optica spectrum disorder, chronic inflammatory demyelinating polyneuropathy) 10. Alternative causes for symptoms, including CNS infections, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial diseases, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatological diseases, Reyes syndrome, or congenital metabolic disorders 11. Known positivity for any neuronal cell surface antibodies other than NMDAR and LGI1 (e.g., caspr2, IgLON5, DPPX, GABAA, and axonal protein 3a) 12. Pregnant or breastfeeding women 13. Tumors other than teratoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a minimum 1-point improvement on the modified Rankin Scale (mRS) at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS scores = 2 at 3, 6, and 12 months after oral steroid treatment.;Proportion of patients with an improvement of at least 1 point in mRS scores and at least 3 points in CASE scores after oral prednisone at 6 and 12 months.;Changes in mRS scores and CASE scores compared to baseline at 3, 6, and 12 months.;The duration during which there is an improvement of at least 1 point in mRS scores and at least 3 points in CASE scores.; Cumulative dose of prednisone within a 12-month period.;Proportion of patients who achieve complete recovery within 6/12 months from onset, and the time to complete recovery.;Proportion of patients experiencing a recurrence within 6/12 months and the time to recurrence.;Proportion of patients initiating immunosuppressive therapy.;Activities of Daily Living (ADL);Clinical Global Impression (CGI);Psychiatric Symptom Assessment;Cognitive Function Assessment; | — |
Countries
China
Contacts
Public ContactZhen Hong
West China Hospital, Sichuan University
Outcome results
None listed