Using magnetic stimulation to assess biomarkers in ALS patients
Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).
This study is testing if a new type of magnetic stimulation can help people with ALS and if it can find useful markers in their blood and urine to track their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Campus Bio-Medico University Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06834269 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of transcranial static magnetic stimulation (tSMS) in patients with Amyotrophic Lateral Sclerosis (ALS). Participants will undergo biemispheric tSMS for two daily sessions over 12 months, while their clinical progression will be monitored using the ALS Functional Rating Scale-Revised (ALSFRS-R). Blood and urine samples will be collected at various intervals to identify potential theranostic biomarkers, and cortical excitability will be assessed through transcranial magnetic stimulation before and after the tSMS treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of ALS, a disease duration of less than 24 months, and specific functional criteria.
Not a fit: Patients with severe bulbar involvement, cognitive impairment, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management and understanding of ALS through the identification of biomarkers and enhanced treatment options.
How similar studies have performed: While the use of tSMS in ALS is a novel approach, similar studies exploring magnetic stimulation techniques have shown promise in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥ 18 * diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria * disease duration \< 24 months * ALSFRS-R \> 30 at the recruitment * ALSFRS-R decline \> 1 in the at least 3-months period before the intervention * normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \> 4) * treatment with riluzole 50 mg x 2/die Exclusion Criteria: * inclusion in other clinical trials * presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy) * unable to perform spirometry due to severe bulbar involvement * contraindications to magnetic fields exposure * pregnancy or breastfeeding * history of epilepsy or seizures * use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines. * cognitive impairment * lack of informed consent
Where this trial is running
Roma, RM
- Fondazione Policlinico Campus Bio-Medico — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Vincenzo Di Lazzaro
- Email: v.dilazzaro@policlinicocampus.it
- Phone: 06 22541 1220
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.