RecruitingRecruiting
Biomarkers of Synaptic Damage in Multiple Sclerosis
NCT03217396 · Neuromed IRCCS
In plain English
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Official title
Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage
About this study
Blood and cerebrospinal fluid samples will be subjected to the procedures required for the isolation of the different components immediately after the withdrawal. Subsequently, the levels of microRNAs, cytokines, chemokines, cell growth factors, neuronal damage markers (tau, phosphorylated and truncated tau, neurofilaments) and mitochondrial (lactate) and free d-amino acids (Objective 1) will be determined. Furthermore, synaptic alterations will be evaluated in the ex vivo chimeric model of MS, using the patch-clamp technique (Objective 2). Genotyping studies will be conducted in order to identify single nucleotide polymorphisms (SNPs) in coding and / or regulating regions of genes (microRNAs or proteins) involved in alterations of the synaptic transmission of MS and its murine experimental model (i.e. SLC1A3, NGFB, PDGFA, etc.), which correlate with specific clinical parameters (i.e. EDSS, BREMS, disease progression index, MS type, disease activity, etc.) and with the levels of potential biomarkers identified
Eligibility criteria
Inclusion Criteria:
1. Male and female patients (age between 18 and 65 years)
2. Diagnosis of MS in accordance with McDonald's (2010 rev) criteria,
3. EDSS between 0 and 5.5 (included),
4. Patients able to provide informed consent to participation in the study
Exclusion Criteria:
1. Inability to provide informed written consent
2. Altered basal blood count
3. Pregnancy or lactation
4. Contraindications for the execution of magnetic resonance imaging with gadolinium
5. Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections
Study design
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2017-11-22
Estimated completion: 2027-09-30
Last updated: 2022-10-28
Interventions
Procedure: lumbar puncture
Primary outcomes
- • Identification of predictive biomarkers of SM using an ex vivo chimeric model (September 01 2020)
Sponsor
Neuromed IRCCS · other
With: IRCCS Multimedica
Contacts & investigators
ContactDiego Centonze, MD · contact · centonze@uniroma2.it · +39 3934444159
ContactMario Stampanoni Bassi, MD · contact · mario_sb@hotmail.it · +39 3460181370
InvestigatorDiego Centonze, MD · principal_investigator, IRCCS Neuromed
All locations (1)
IRCCS NeuromedRecruiting
Pozzilli, Isernia, Italy