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Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis

Serum Neurofilaments Light Chain and GFAP (Glial Fibrillary Acidic Protein) in Atypical Idiopathic Inflammatory Demyelinating Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04201470
Acronym
AMIS
Enrollment
58
Registered
2019-12-17
Start date
2019-12-09
Completion date
2022-05-23
Last updated
2025-09-30

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

Conditions

Controls, Multiple Sclerosis, Progressive Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis

Keywords

Atypical multiple sclerosis, Cavitary multiple sclerosis, Myelocortical multiple sclerosis

Brief summary

Idiopathic inflammatory disorders of the central nervous system include various disorders of which multiple sclerosis is the most common. Besides multiple sclerosis, other distinct disorders including for example anti-AQP4 (aquaporine-4) and anti-MOG (Myelin oligodendrocyte glycoprotein) NMOSD (Neuromyelitis optica spectrum disorder) have been well characterized and are now known to be distinct from MS. some patient belonging to MS spectrum have recently being characterized but unusual MRI findings have mimicking inherited leukoencephalopathies and leukodystrophies. Whether these patients with atypical phenotype represent a separate disease distinct from MS or belong to MS spectrum is not clear. The objectives are to evaluate a series of 15 patients with atypical forms of MS using non-conventional MRI techniques and biological biomarkers (serum neurofilaments light chain) and to compare them with classical MS patients (15 relapsing remitting patients and 15 progressive patients) and 15 controls. the hypothesize is that these patients with atypical MS have a more severe neurodegenerative process.

Interventions

OTHERBlood withdrawal

Measurement of serum neurofilaments light chain and GFAP

OTHERMRI

Cervical and cerebral MRI without contrast injection

OTHERNeurologic / neuropsychologic tests - Patients

EDSS (Expanded Disability Status Scale), NHPT (Nine Hole Peg Test), T25FW (Timed 25-Foot Walk Test), 6MWT (Six-Minute Walk Test), CSCT (Computerized version of the Symbol Digit Modalities Test)

OTHERNeurologic / neuropsychologic tests - Controls

NHPT, T25FW, CSCT

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The subject must have given his informed consent and signed the consent form (if patient is protected by the law due to the study pathology, the consent will be signed his tutor or guardian ; if patient is unable to read or sign the consent form due to the study pathology, the consent will be signed by his family/trusted person) * The subject is at least 18 years old (≥). * Affiliate or beneficiary of a social security scheme Inclusion criteria specific to Patients: * Patients with atypical form of MS * OR patients with RRMS (Relapsing-Remitting Multiple Sclerosis) * OR patients with PPMS (Primary Progressive Multiple Sclerosis) (Patients will be matched on EDSS score (+/-1) and age (+/-5) ; Controls will be matched with patients on age)

Exclusion criteria

* Pregnant or lactating women. * Vulnerable people. * Simultaneous participation in any other research protocol. * Contraindication to the realization of an MRI (ferromagnetic ocular or cerebral foreign bodies close to nerve structures, pace-maker, cochlear implants) * Claustrophobic subject * Subject presenting a neurodegenerative disease (Parkinson, Alzheimer ...) * Subject presenting psychiatric disorders like psychosis, excluding anxio-depressive episode * Subject presenting a systemic pathology with neurological manifestation * Subject presenting anterior or evolutionary neurological pathology other than the 3 entities defined in the inclusion criteria * Subject presenting or having had a history of severe group 2 or 3 head trauma according to the Masters classification * Patient receiving high dose corticosteroid therapy in the 3 months prior to inclusion in the study

Design outcomes

Primary

MeasureTime frameDescription
Serum neurofilaments light chainBetween baseline (day 0) and day 60Evaluation of serum neurofilaments light chain levels in patients with atypical MS and comparison with controls and patients with classical MS

Secondary

MeasureTime frameDescription
Serum GFAPBetween baseline (day 0) and day 60Evaluation of serum GFAP levels in patients with atypical MS and comparison with controls and patients with classical MS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026