An observational study in Multiple Sclerosis, MS, Neuromyelitis Optica Spectrum Disorders and Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions.
The main questions it aims to answer are:
Question 1: Clarify the clinical characteristics and prognostic factors of various diseases (MS, NMOSD, MOGAD, etc.) within IIDD in the Chinese population.
Question 2: Analyze the relationship between biomarkers and the occurrence, progression, and prognosis of CNS IIDD cases in our hospital.
Participants will
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 450 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are aged between 18 and 65 years and diagnosed with central nervous system idiopathic inflammatory demyelinating diseases
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
Diagnosis meets the 2015 IPND diagnostic panel standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
Diagnosis meets the 2023 international expert panel recommended standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
Diagnosis meets the diagnostic criteria for ADEM
Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
First occurrence of CNS inflammatory demyelinating event, not yet diagnosable as MS, NMOSD, MOGAD, ADEM, or other definitive types of central nervous system demyelinating diseases, with symptoms and signs lasting more than 24 hours
Relapse
Must meet the following criteria：① Appearance of new symptoms or worsening of existing symptoms;② Symptoms attributed to CNS IIDD;③ Duration ≥24 hours;④ Increase in clinical scores (e.g., EDSS);⑤ Imaging or electrophysiological tests clearly showing new responsible lesions.
Time frame: Through study completion, an average of 5 years
Long-term neurological function
Assessed using the Expanded Disability Status Scale (EDSS)，EDSS score ranges from 0 to 10, with 0 indicating a normal healthy state, 10 indicating death, and higher scores reflecting more severe disability.
Time frame: Through study completion, an average of 5 years
Long-term neurological function
Assessed using the Optic Spinal Impairment Scale (OSIS) and its sub-scores, OSIS score ranges from 0 to 25, and higher scores reflect more severe disability. OSIS sub-score ranges from 0 to 5-8, and higher scores reflect more severe in each component assessment.
Time frame: Baseline, six months, one year, two years, and average three years
Sub-scores of the Expanded Disability Status Scale (EDSS)
EDSS sub-score ranges from 0 to 5 or 6, with 0 indicating a normal healthy state, higher scores indicating worse neurological functions.
Time frame: Baseline, six months, one year, two years, and average three years
Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness
The thickness is measured by machines by milimetres
Time frame: Baseline, six months, one year, two years, and average three years
Changes in humoral immune markers
The levels of neurofilament light chain (NfL), soluble GFAP, soluble TREM2, and other potential biomarkers are measured in g/ml.
Time frame: Baseline, six months, one year, two years, and average three years
Changes in pathogenic antibody titers
Titers of antibodies for MOG, AQP4, MBP, and AFO in iu/l
Time frame: Baseline, six months, one year, two years, and average three years
P100 amplitude of visual evoked potentials
Amplitude in volts
Time frame: Baseline, six months, one year, two years, and average three years
P100 latency of visual evoked potentials
Latency in seconds
Time frame: Baseline, six months, one year, two years, and average three years
Latency of somatosensory evoked potentials;
Latency in seconds
Time frame: Baseline, six months, one year, two years, and average three years
Latency of brainstem auditory evoked potentials;
Latency in seconds
Time frame: Baseline, six months, one year, two years, and average three years
Amplitude of somatosensory evoked potentials;
Amplitude in volts
Time frame: Baseline, six months, one year, two years, and average three years
Amplitude of brainstem auditory evoked potentials;
Amplitude in volts
Time frame: Baseline, six months, one year, two years, and average three years
Recording of adverse reactions
Time frame: Baseline, six months, one year, two years, and average three years
Follow-up of common adverse reactions
Time frame: Baseline, six months, one year, two years, and average three years
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2035, 143 months after the start.
Of 334 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 73. This study's planned 143 months is above that.
Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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