Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).

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

This study aims to evaluate safety and efficacy of tSMS in ALS patients and to obtain preliminary data about the effects of tSMS on cortical excitability.

To this purpose, 40 ALS patients will be recruited and randomized to real or sham tSMS. After at least 3 months follow-up, they will undergo tSMS, daily for 120 min, at home, for 6 consecutive months.

Clinical status will be tested before, during and after the stimulation period. Moreover, cortical excitability will be tested by transcranial magnetic stimulation (TMS) before and after the stimulation period.

Inclusion Criteria:

• age between 18 and 75 years
• diagnosis of 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 (FVC > 80% and ALSFRS-R items 10,11,12 > 4) at the recruitment
• treatment with riluzole 50 mg x 2/die

Exclusion Criteria:

• inclusion in other clinical trials
• presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
• contraindications to magnetic fields exposure
• pregnancy or breast-feeding
• history of epilepsy or seizures
• assumption of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
• cognitive impairment
• lack of informed consent