NCT06834269

Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.

Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring: * levels of NF-L and other potential innovative biomarkers, * clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3). Moreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

Type	Name	Description
DEVICE	Transcranial magnetic stimulation (tSMS)	Transcranial static magnetic stimulation (tSMS) will be delivered simultaneously to both hemispheres, at the motor cortex (M1), via magnets housed in a helmet.

Timeline

• Start date: 2024-12-02
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-02-19
• Last updated: 2025-02-28

Locations

1 site across 1 country: Italy