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Exploring Biomarkers for New-Onset Refractory Status Epilepticus (NORSE) Using Olink Proteomics

Exploring Biomarkers for New-Onset Refractory Status Epilepticus (NORSE) Using Olink Proteomics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108989
Enrollment
Unknown
Registered
2025-09-10
Start date
2024-12-10
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

New-onset Refractory Status Epilepticus

Interventions

NORSE group &Control group:none

Sponsors

The Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Patients: 1.Patients aged 14 to 80 years, either gender; 2.No prior history of epilepsy or other neurological diseases, and no identifiable structural, toxic, or metabolic etiologies; 3.Presentation with refractory status epilepticus (RSE), defined as seizure duration longer than 5 minutes, or recurrent seizures without recovery of consciousness between episodes; 4.Diagnosis of exclusion: After comprehensive evaluation (including blood tests, cerebrospinal fluid analysis, imaging, autoimmune antibody testing, viral screening, etc.), no clear etiology such as tumor, metabolic disorder, intoxication, or genetic disease is identified, and the cause remains unknown within 48–72 hours. If the patient has a history of fever between 2 weeks and 24 hours prior to seizure onset, they are classified as having Febrile Infection-Related Epilepsy Syndrome (FIRES), a specific subtype of NORSE. Inclusion Criteria for Healthy Controls: 1.Individuals aged 14 to 80 years, either gender; 2.No history of epilepsy or other neurological diseases, to ensure a clear distinction in health status compared to NORSE patients; 3.No severe hepatic or renal insufficiency or other systemic diseases that may interfere with serum sample analysis; 4.Understanding of the study content and willingness to participate, with signed informed consent.

Exclusion criteria

Exclusion criteria: Patient Exclusion Criteria: 1.Definite Etiology: Status epilepticus caused by definite acute or active structural, toxic, or metabolic reasons, such as traumatic brain injury, brain tumor, poisoning, etc. 2.Medical History: Active epilepsy or other pre-existing neurological diseases; 3.Prior Treatments: Received immunotherapy or anti-inflammatory treatment before enrollment, which may affect the expression of serum protein markers; 4.Inability to Consent or Follow-up: Inability to understand the study content or refusal to sign the informed consent form, or inability to undergo regular follow-ups and serum sample collection during the study period; Healthy Control Exclusion Criteria: 1.Neurological Diseases: Presence of epilepsy or other neurological diseases to ensure a clear distinction between the health status of the control group and NORSE patients; 2.Systemic Diseases: Severe hepatic or renal insufficiency or other systemic diseases that may interfere with serum sample test results. 3.Inability to Consent: Inability to understand the study content or refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Serum protein biomarkers in NORSE patients;Comparative analysis of differentially expressed immune-response and inflammation-related proteins in serum samples from healthy individuals and patients with NORSE;

Countries

China

Contacts

Public ContactZhang Haiqing

Zunyi Medical University,Affiliated Hospital of Medical University

1143883711@qq.com+86 130 4859 1456

Outcome results

None listed

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