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.
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
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