Clinical Manifestations | Additional Evidence |
---|---|
≥2 attacksa; with ≥2 objective clinical evidence of lesions or the presence of 1 objective clinical evidence of lesions with reasonable historical evidence of prior attacksb | Nonec |
≥2 attacksa; with 1 lesion of objective clinical evidence | Evidence proving the spatial dissemination of lesions (DIS): (1) At least 2 of the typical MS regions in the CNS (periventricular, juxtacortical, infratentorial, and spinal cord)d have ≥1 T2 lesion; (2) or awaiting subsequent clinical attacks involving different parts of the CNSa |
1 attacka; with ≥2 lesions of objective clinical evidence | Evidence proving the temporal dissemination of lesions (DIT): (1) Simultaneously presence of asymptomatic gadolinium-enhancing and non-enhancing lesions at any time; (2) or new T2 and/or gadolinium-enhancing lesions (1 or more) visible in subsequent MRI scans, regardless of the temporal reference of the baseline MRI; (3) or awaiting a second clinical attacka |
1 attacka; with 1 lesion of objective clinical evidence (Clinical Isolated Syndrome) | Evidence proving both spatial dissemination (same as above DIS) and temporal dissemination (same as above DIT) |
Suggestive of MS with hidden neurological dysfunction progression (Primary Progressive MS) |
Disease progression for 1 year (determined retrospectively or prospectively) along with at least 2 of the following 3 criteriad: (1) Evidence of spatial dissemination of brain lesions: at least 1 T2 lesion in characteristic MS regions (periventricular, juxtacortical, or infratentorial); (2) Evidence of spatial dissemination of spinal cord lesions: at least 2 T2 lesions in the spinal cord; (3) Positive cerebrospinal fluid [evidence of oligoclonal bands from isoelectric focusing or elevated IgG index] |
Explanation
MS: Completely meets the criteria, and no other disease can better explain the clinical manifestations.
Possible MS: Does not completely meet the criteria, with clinical manifestations suspecting MS.
Not MS: Diagnosis of other diseases found during follow-up and assessment that can better explain clinical manifestations.
aAttacks (relapses, exacerbations): refer to a typical acute inflammatory demyelinating event of the CNS, as described by the patient or objectively observed, lasting at least 24 hours, excluding fever or infection. Attacks must have a medical record of objective neurological examination and should exclude events lacking reasonable and objective neurological examination and medical records. Some prior events that meet MS clinical symptoms and developmental evolution characteristics can provide reasonable evidence supporting earlier demyelinating events. However, reports of paroxysmal symptoms (previous or current) should consist of multiple segmental attack events lasting at least 24 hours. Before making an MS diagnosis, at least 1 attack must be confirmed by evidence (objective neurological examination; visual evoked potential evidence that may precede the patient's description of visual dysfunction; or MRI findings showing demyelinating lesions in the CNS that can explain previous neurological symptoms).
bClinical diagnosis based on 2 attacks with objective neurological examination positive findings is the most reliable. In the absence of objective neurological examination positive findings, reasonable historical evidence from a previous attack can include supporting prior inflammatory demyelinating events and related clinical symptoms and their evolution characteristics; however, at least 1 attack must be supported by objective findings.
cNo additional tests are required. However, it is best that any MS diagnosis is made based on these criteria with imaging assistance. If imaging or other tests (such as cerebrospinal fluid) are conducted and yield negative results, extreme caution is required before making an MS diagnosis, and consideration must be given to whether other diagnoses need to be made. Objective evidence must exist to support the MS diagnosis, and no other more reasonable disease explanation for the clinical manifestations can be found.
dGadolinium-enhancing lesions are not required; relevant symptoms caused by brainstem or spinal cord lesions should be excluded from typical symptomatic lesions (except for excluding neuromyelitis optica).