Effects of Transcranial Static Magnetic Field Stimulation (tSMS) in Progressive Multiple Sclerosis

Launched by NEUROMED IRCCS · Mar 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called transcranial static magnetic field stimulation (tSMS) on patients with progressive multiple sclerosis (PMS). The goal is to see if this non-invasive method can help slow down disability progression in patients who experience a specific type of symptoms related to their spinal cord. The study will involve 40 patients who meet certain criteria, such as being between 18 and 65 years old and diagnosed with progressive MS that affects their motor functions. Participants must be stable on their current treatments and not have any other serious medical conditions.

During the trial, eligible participants will undergo either real or sham (fake) tSMS treatments at home for a full year. They will use the device for two hours each day, and neither the participants nor the researchers will know which treatment is real. Throughout the study, the researchers will monitor changes in the patients' abilities and overall health through various tests and evaluations. This trial aims to explore whether tSMS can improve the brain's ability to compensate for damage caused by MS, potentially leading to better outcomes for those living with the disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability to give written informed consent to the study
• • Age range 18-65 years
• • Diagnosis of primary of secondary progressive MS according to 2017 revised Macdonald's criteria (Thompson et al., 2017), presenting with signs of symptoms of progressive dysfunction of the corticospinal tract
• • EDSS ≤ 6,5
• • Ability to participate to the study protocol
• • No or stable (at least six months) DMT or rehabilitative treatments before study entry, and willingness not to change these therapies (including cannabinoids, SSRI, baclofen) during the study.
• Exclusion Criteria:
• • Relapsing-remitting MS or progressive MS presenting with signs of symptoms other than those typical of the ascending myelopathy phenotype (i.e. progressive cerebellar or cognitive involvement)
• • Female with positive pregnancy test at baseline or having active pregnancy plans
• • Comorbidities for which synaptic plasticity may be altered (i.e., Parkinson's disease, Alzheimer's disease, stroke)
• • Contraindications to TMS
• • History or presence of any unstable medical condition such as malignancy or infection
• • Use of medications with increased risk of seizures (i.e. Fampridine, 4-Aminopyridine)
• • Concomitant use of drugs that may alter synaptic transmission and plasticity (L-dopa, antiepileptics)