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

Study Overview
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Brief Summary
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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.

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

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Device: tSMS
* Device: sham tSMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real tSMS<br>tSMS will be delivered by a magnet applied to M1, bilaterally (120 min daily, for 6 months). Magnet will be kept in position by a plastic helmet. | Device: tSMS<br>* tSMS delivered on bilateral motor cortex<br>|
| Sham Comparator: sham tSMS<br>A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation. | Device: sham tSMS<br>* sham tSMS delivered on bilateral motor cortex by a non-magnetic steel cylinder, with same size, weight and appearance of the magnet used for real tSMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | 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 six months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Incidence of adverse events during the stimulation period | 6 months | 
| Compliance | Number of stimulation sessions actually completed by each patient | 6 months | 
| 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. | 6 months | 
| Effect on motor evoked potentials (MEP) size | Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic Lateral Sclerosis, ALS, transcranial magnetic stimulation, static magnetic field, tSMS