Transcranial magnetic field stimulation for progressive multiple sclerosis
Effects of Transcranial Static Magnetic Field Stimulation (tSMS) in Progressive Multiple Sclerosis
NA · Neuromed IRCCS · NCT05811013
This study is testing whether a new type of brain stimulation can help adults with progressive multiple sclerosis feel better and slow down their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Neuromed IRCCS (other) |
| Locations | 1 site (Pozzilli, Isernia) |
| Trial ID | NCT05811013 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial static magnetic field stimulation (tSMS) on patients with progressive multiple sclerosis (PMS). It aims to address the abnormalities in synaptic transmission caused by inflammation in the brains of MS patients, which can lead to neurodegeneration and worsening symptoms. Participants will receive either active tSMS or a sham treatment to evaluate the potential benefits of this non-invasive intervention on disability progression and cortical plasticity. The study includes adults aged 18-65 with a confirmed diagnosis of PMS and specific clinical criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with primary or secondary progressive MS and specific clinical symptoms related to corticospinal tract dysfunction.
Not a fit: Patients with relapsing-remitting MS or those with significant cognitive or cerebellar involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help slow down disability progression in patients with progressive multiple sclerosis.
How similar studies have performed: While the approach of using tSMS is relatively novel, similar studies exploring non-invasive brain stimulation techniques have shown promising results in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Pozzilli, Isernia
- IRCCS Neuromed — Pozzilli, Isernia, Italy (RECRUITING)
Study contacts
- Study coordinator: Diego Centonze, MD, PhD
- Email: centonze@uniroma2.it
- Phone: +39 0865 929170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Progressive Multiple Sclerosis, transcranial Static Magnetic Field Stimulation, disability progression, cortical hyperexcitability, cortical plasticity