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A Single-Center Prospective Cohort Study on the Disease Burden of Patients with Autoimmune Encephalitis

A Single-Center Prospective Cohort Study on the Disease Burden of Patients with Autoimmune Encephalitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121011
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-24
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Encephalitis

Interventions

Other autoimmune encephalitis:NA
Anti-NMDAR encephalitis group:NA

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 14–75 years; 2. Meet the 2016 international diagnostic criteria for autoimmune encephalitis (AE), with definite AE-associated antibodies detected in serum/cerebrospinal fluid (anti-NMDAR, anti-GABABR, anti-LGI1, anti-CASPR2, or other well-recognized AE antibodies); 3. Time from diagnosis <= 3 months (to ensure capture of early disease burden characteristics); 4. Voluntary signed informed consent by the patient or their legal guardian (for minors/individuals without full civil capacity); 5. Able to cooperate and complete the 12-month follow-up (including questionnaire completion, clinical re-examination, telephone follow-up, etc.); 6. Able to provide complete medical records (fee lists, treatment regimens, examination reports) for data verification.

Exclusion criteria

Exclusion criteria: 1. A definite diagnosis of other central nervous system diseases, such as infectious encephalitis (HSV, Epstein–Barr virus, etc.), metabolic encephalopathy, cerebrovascular disease, brain tumor, etc. 2. Participation in >= 2 other clinical studies simultaneously, or a washout period of less than 1 month since the last clinical trial medication. 3. Presence of severe underlying diseases including hepatic and renal insufficiency, coagulation dysfunction, etc., that prevent completion of long-term follow-up. 4. Caregivers refuse to provide information related to economic status and quality of life. 5. Incomplete medical records, making it impossible to extract medical cost or survival data.

Design outcomes

Primary

MeasureTime frame
Total cumulative economic burden at 12 months;

Secondary

MeasureTime frame
Neurological function scores;Health related quality of life;

Countries

China

Contacts

Public ContactXiangjun Chen

Huashan Hospital, Fudan University

xiangjchen@fudan.edu.cn+86 21 5288 8159

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026