Health TrialsbyHealthPanel

Biomarkers in Autoimmune Disease of Nervous System

ConditionsAutoimmune Diseases of the Nervous SystemNeuromyelitis Optica Spectrum DisorderMultiple SclerosisGuillain-Barre SyndromeAcute Disseminated EncephalomyelitisAutoimmune EncephalitisStiff-Person SyndromeMyasthenia GravisChronic Inflammatory Demyelinating PolyradiculoneuropathyIdiopathic Inflammatory MyopathiesAutoimmune Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Clinical diagnosis with autoinflammatory diseases of the nervous system, including: Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.

sex and age-matched healthy individuals

Disqualifiers

Known history of primary immunodeficiency (innate or acquired).

Patients with severe central nervous system, pulmonary, or other systemic infections.

Patients with secondary central nervous system demyelinating lesions, such as those caused by vasculitis, systemic lupus erythematosus, and Sjögren's syndrome.

Patients with vascular (including hemorrhagic and ischemic), hereditary metabolic, neoplastic, or toxic diseases.

Trial population

Patients with neurological autoimmune disease admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from June 1, 2024 - May 31, 2034.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • biomaker levels

    Diagnostic test

    this study will discover and validate novel biomarkers (including blood, feces, bone marrow and lymph nodes etc al) of various neurological autoimmune diseases

Treatment groups

50,000 Participants
are divided into 2 treatment groups
Group A: autoimmune disease1 intervention
Group B: health control1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

Death during the follow-up in every single reason

Time frame
10 years

Secondary outcomes

1

Autoimmune disease of any kind

Brain or spinal MRI scans will be used to detect the presence of any autoimmune disease, including multiple sclerosis, neuromyelitis optica spectrum disorder, acute disseminated encephalomyelitis, autoimmune encephalitis, Guillain-Barré syndrome, and myasthenia gravis.

Time frame
10 years

Other outcomes

1

Accumulated total active MRI lesions

the number of accumulate total active MRI lesions after CT103A infusion

Time frame
10 years
2

Expanded Disability Status Scale (EDSS) score

EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.

Time frame
10 years
3

Modified Rankin Scale

Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. A favorable outcome was characterized as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to 6.

Time frame
10 years
4

Visual acuity

Corrected visual acuity is determine by Snellen E chart held at a distance of 5 meters. Higher score indicates better vision.

Time frame
10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov
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