Using miR-142-3p to identify synaptopathy in Multiple Sclerosis

Clinical Relevance of miR-142-3p as Potential Biomarker of Synaptopathy in Multiple Sclerosis

This study is testing if a specific microRNA can help identify nerve damage in people with Multiple Sclerosis to improve treatment options.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Neuromed IRCCS (other)
• Locations: 1 site (Pozzilli, Isernia)
• Trial ID: NCT03999788 on ClinicalTrials.gov

What this trial studies

This study investigates the role of miR-142-3p as a potential biomarker for synaptopathy in patients with Multiple Sclerosis (MS). It aims to explore how this microRNA correlates with excitotoxic synaptic dysfunction and disease progression. Participants will undergo lumbar puncture and blood withdrawal, along with an Intermittent theta burst stimulation (iTBS) therapeutic protocol to assess spasticity. The study seeks to establish a reliable biomarker that could lead to earlier interventions and improved therapeutic outcomes for MS patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 with a confirmed diagnosis of MS and an EDSS score between 0 and 6.

Not a fit: Patients with other neurological diseases, unstable medical conditions, or contraindications to the study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new biomarker for early detection of synaptopathy in MS, potentially leading to better treatment strategies.

How similar studies have performed: While the approach of using microRNAs as biomarkers is emerging, this specific investigation into miR-142-3p in MS is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Ability to provide written informed consent to the study;
* Diagnosis of MS definite according to 2010 revised McDonald's criteria (Polman et al., 2011);
* Age range 18-65 (included);
* EDSS range between 0 and 6 (included);
* Ability to participate to the study protocol.

Exclusion Criteria:

* Inability to provide written informed consent to the study;
* Altered blood count;
* Female with positive pregnancy test at baseline or having active pregnancy plans in the following months after the beginning of the protocol;
* Contraindications to gadolinium (MRI);
* Contraindications to TMS;
* Patients with comorbidities for neurological disease other than MS, included other neurodegenerative chronic diseases or chronic infections (i.e tubercolosis, infectious hepatitis, HIV/AIDS);
* Unstable medical condition or infections;
* Use of medications with increased risk of seizures (i.e. Fampridine, 4- Aminopyridine);
* Concomitant use of drugs that may alter synaptic transmission and plasticity (cannabinoids, L-dopa, antiepiletics, nicotine, baclofen, SSRI, botulinum toxin).

Where this trial is running

Pozzilli, Isernia

• IRCCS Neuromed — Pozzilli, Isernia, Italy (RECRUITING)

Study contacts

• Principal investigator: Diego Centonze, MD — IRCCS Neuromed, Pozzilli, Isernia Italy
• Study coordinator: Diego Centonze, MD

Conditions: Multiple Sclerosis, Spasticity, microRNA, synaptopathy, lower limb spasticity, transcranial magnetic stimulation, repetitive TMS stimulation protocol, GLAST/EAAT1