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Prospective multicenter study of clinical, neuroImaging, and electroencephalogram features in antibody negative autoimmunity encephalitis (CLIEN-AE)

Prospective multicenter study of clinical, neuroImaging, and electroencephalogram features in antibody negative autoimmunity encephalitis (CLIEN-AE)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068212
Enrollment
Unknown
Registered
2023-02-10
Start date
2023-02-15
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

seizure

Interventions

Patients with autoimmune encephalitis with negative antibody:N/A

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Agree and sign informed consent; 2. Patients aged 5-80 years; 3. Previous health, no history of seizures, new seizures within one year, and the frequency of seizures >= 1; 4. All epileptic patients with unknown etiology and APE2 score >= 4; 5. NMDAR, AMPA1, AMPA2, LGI1, CASPR2, GABABR, IgLON5, DPPX, GAD65, MOG, GABAAR, GlyR1, DRD2, mGluR5, mGluR1, Neurexin-3a, ganglionic AChR, KLHL11, AQP4, GFAP antibody TBA+CBA were all negative and had response to immunotherapy.

Exclusion criteria

Exclusion criteria: 1. Epilepsy caused by fetal and perinatal brain injury; 2. Epilepsy or seizures due to/associated with genetics, brain tumors, brain trauma, cortical dysplasia, cerebrovascular diseases, neurodegenerative diseases, metabolic and/or toxic encephalopathy, systemic or primary central nervous system (CNS) vasculitis (appropriate diagnosis and treatment if available); 3. Herpes virus, enterovirus, respiratory virus, JC virus, measles virus, Japanese encephalitis virus B, HIV virus, tuberculosis and other mycobacteria, syphilis, fungi, mycoplasma, toxoplasma, cryptococcus and other microbial infections caused by encephalitis/encephalopathy; 4. APE2 score = 2 cm) lesions primarily involving white matter; low signal lesions in white matter in rare cases; abnormal brain MRI: diffuse, blurred, large (>= 2 cm) lesions involving white matter; Deep gray matter abnormalities (such as thalamus or basal ganglia) may occur; (4) No new clinical manifestations or MRI lesions may occur 3 months after symptom onset; (5) Other causes may be reasonably excluded; 6. Hashimoto encephalopathy; 7. Bickerstaff encephalitis; 8. Seizures associated with metabolic causes such as abnormal blood glucose, sodium, liver and kidney function; 9. Patients with incomplete data and lost follow-up; 10. Those who have not signed the informed consent.

Design outcomes

Primary

MeasureTime frame
Clinical features;EEG;MRI;

Countries

China

Contacts

Public ContactHan Xiong

Henan Provincial People's Hospital

shengyiHX123@163.com+86 138 3717 1615

Outcome results

None listed

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