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Clinical study of cerebrospinal fluid immunoglobulin G oligoclonal band detection in Chinese patients with multiple sclerosis

Clinical study of cerebrospinal fluid immunoglobulin G oligoclonal band detection in Chinese patients with multiple sclerosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040363
Enrollment
Unknown
Registered
2020-11-28
Start date
2020-11-23
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

Multiple Sclerosis

Interventions

Gold Standard:Isoelectric focusing electrophoresis
index&#32
24-hour&#32
intrathecal&#32
synthesis&#32
rate&#32
CSF-OCB&#32

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: MS patient group: 1) 14 to 65 years old, Chinese citizens, male or female; 2) The diagnosis of multiple sclerosis (MS) needs to be carried out in the cooperative hospitals of this project, the corresponding certified MS center specialist clinics or neuroimmunology specialist clinics. Two or more experienced specialists are recommended to rule out other possible diseases and be independent in making a diagnosis of MS; 3) Course of disease: From the first symptoms to the time of enrollment in the study, the course of disease is more than 6 months (the OB may not be positive if the course is too short, see Link H. 2016 review); 4) The diagnosis refers to the 2010 McDonald standard (excluding OCB standard); 5) >=2 clinical seizures, through re-clinical seizures suggesting that different parts of the central nervous system are involved or MRI shows spatial multiple); 1 clinical seizure is through re-clinical seizures or MRI shows temporal multiple; 1 clinical seizure is through re-clinical Seizures suggest that different parts of the central nervous system are involved or MRI shows multiple occurrences in space and re-clinical seizures or MRI shows multiple occurrences in time; 6) Have done OCB examination of cerebrospinal fluid; 7) Able to understand and sign informed consent; Control group 1 (patients with other inflammatory diseases of the nervous system): 1) 14 to 65 years old, Chinese citizens; 2) Two or more experts confirm that the diagnosis is consistent with Guillain-Barre syndrome, acute myelitis, brainstem encephalitis, viral encephalitis, tuberculous encephalitis, bacterial encephalitis, neurolupus and other inflammatory diseases of the nervous system 3) Able to understand and sign informed consent; 4) Able to complete lumbar puncture inspection. Control group 2 (patients with non-inflammatory diseases of the nervous system) 1) 14 to 65 years old, Chinese citizens; 2) 2 or more experts confirm that the diagnosis is consistent with non-inflammatory diseases of the nervous system such as epilepsy, migraine, cerebrovascular disease, Parkinson's disease, motor neuron disease, etc. 3) Able to understand and sign informed consent; 4) Able to complete lumbar puncture inspection.

Exclusion criteria

Exclusion criteria: MS patient group: 1) Patients with complicated pregnancy; 2) Those who have participated in other clinical researches in the past 3 months; 2) 2 or more experts do not think it is necessary to consider patients with multiple sclerosis (MS) diagnosis; 3) AQP4-IgG, MOG-IgG and other patients with positive antibodies related to known demyelinating diseases; 4) Patients with lumbar puncture contraindications or patients who cannot accept lumbar puncture; 5) Patients with combined infection (including latent) and malignant tumors; 6) Other situations deemed unsuitable by researchers. Control group 1 (patients with other inflammatory diseases of the nervous system) 1) Patients with pregnancy; 2) Those who have participated in other clinical research in the past 3 months; 3) Patients with lumbar puncture contraindications or patients who cannot accept lumbar puncture; 4) Patients with combined infection (including latent) and malignant tumors; 5) Other situations deemed unsuitable by researchers. Control group 2 (patients with non-inflammatory diseases of the nervous system) 1) Patients with pregnancy; 2) Those who have participated in other clinical researches in the past 3 months; 3) Patients with lumbar puncture contraindications or patients who cannot accept lumbar puncture; 4) Patients with combined infection (including latent) and malignant tumors; 5) Other situations deemed unsuitable by researchers.

Design outcomes

Primary

MeasureTime frame
IgG Index;CSF 24-hour intrathecal synthesis rate;CSF-OCB testing type;CSF-OCB positive rate;

Countries

China

Contacts

Public ContactChen Xiangjun

Huashan Hospital, Fudan University

xiangjchen@fudan.edu.cn+86 18221382327

Outcome results

None listed

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