Studying Biomarkers of Nerve Connection Damage in Multiple Sclerosis
Observes blood and spinal fluid samples from adults with multiple sclerosis and other diseases.
Key facts
- Who runs it
- Neuromed IRCCS
- Where
- Pozzilli, ItalySee the site
- Trial code
- Registry title
- Biomarkers of Synaptic Damage in Multiple Sclerosis
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 22 Nov 2017
- Expected to end
- 30 Sept 2027
- Type of study
- Observational, 3 groups
- Treatments tested
- lumbar puncture
- Record updated
- 28 October 2022
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with multiple sclerosis (MS). People with other nerve diseases and healthy people are studied as control groups.
- Age
- 18 to 65 years
- Sex
- Men and women
- Disease stage
- MS diagnosed by McDonald's (2010 rev) criteria, with an EDSS score from 0 to 5.5 (included)
Main reasons for not taking part
- Cannot give informed written consent
- Altered basal blood count
- Pregnancy or lactation
- Contraindications for magnetic resonance imaging with gadolinium
- Significant clinical conditions in addition to MS or other chronic neurodegenerative diseases, including latent viral infections
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Male and female patients (age between 18 and 65 years)
- Diagnosis of MS in accordance with McDonald's (2010 rev) criteria,
- EDSS between 0 and 5.5 (included),
- Patients able to provide informed consent to participation in the study
Who cannot take part
- Significant clinical conditions in addition to SM or other chronic neurodegenerative diseases including latent viral infections
- Altered basal blood count
- Inability to provide informed written consent
- Pregnancy or lactation
- Contraindications for the execution of magnetic resonance imaging with gadolinium
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Italy
- IRCCS NeuromedPozzilli, ItalyContact: Stefania PassarelliTaking people
About the trial
What the trial wants to find out
A prospective and retrospective cohort study of about five years will be performed on blood and cerebrospinal fluid samples taken for diagnostic reasons from recruited patients within the Neuromed Neurology Unit. Subjects with other chronic neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD) and Parkinson's disease (PD), and healthy subjects subjected to blood sampling and / or lumbar puncture for clinical reasons will be recruited As control groups.
The 3 groups in the trial
- multiple sclerosis patients
lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis
Treatment: lumbar puncture
- neurodegenerative disease patients
lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis
Treatment: lumbar puncture
- control subjects
lumbar puncture, microRNAs quantification in blood and CSF samples, SNPs analysis
Treatment: lumbar puncture
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Identification of New Biomarkers Useful to Define the Course of Multiple Sclerosis and Study of the Mechanisms That Promote Synaptic Damage
- Plain-language title
- Studying Biomarkers of Nerve Connection Damage in Multiple SclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT03217396, who can take part
- Record updated
- 28 October 2022