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
Single group
Transcranial magnetic stimulation (tSMS)
DeviceTranscranial static magnetic stimulation (tSMS) will be delivered simultaneously to both hemispheres, at the motor cortex (M1), via magnets housed in a helmet.
NfL reduction
The potential reduction of NfL during treatment is monitored by blood samples collected at baseline, and then , every 3 months during the treatment
Monthly Progression Rate (MPR)
MPR is derived from the comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of at least three months before the treatment, and the period of twelve months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points.
New Potential Theranostic Biomarkers Assay
Investigation of potential theranostic biomarkers in blood samples (YKL-40, TDP43) and urine samples (p75ECD), collected at baseline and evrey three months during the treatment
Effect on resting motor threshold (RMT) and active motor threshold (AMT)
Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.
Effect on motor evoked potentials (MEP) size
Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
Click on the lead sponsor to view all of their trials.
