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Introduction: Enhanced glutamatergic transmission leading to motor neuron death is considered the major pathogenetic mechanism of amyotrophic lateral sclerosis (ALS). Motor cortex excitability can be suppressed by transcranial static magnetic stimulation (tSMS), thus tSMS can be evaluated as a potential treatment for ALS. Our aim was to investigate the efficacy and safety of tSMS in ALS.
Methods: In this trial, we randomly assigned ALS patients to receive daily tSMS or placebo stimulation for 6 months. For each participant we calculated mean disease monthly progression rate (MPR) using the ALS Functional Rating Scale-Revised (ALSRFS-R). The primary outcome was the difference in MPR before and after the beginning of treatment. Secondary outcomes were safety, tolerability, and compliance. A long-term follow-up of 18 months was performed in all patients who completed the six-month treatment considering a composite endpoint event (tracheostomy or death).
Results: 40 participants were randomly assigned to real (n=21) or placebo stimulation (n=19). The MPR did not show statistically significant differences between the two arms during the pre-treatment and treatment period. The treatment was feasible and safe, with high compliance. At the end of the long-term follow-up of 18 months, patients of real group had a statistically significant higher tracheostomy-free survival compared with patients of placebo group.
Conclusions: tSMS did not modify disease progression during the 6 months of treatment. However, long-term follow-up revealed a substantial increase in tracheostomy free survival in patients treated with real stimulation supporting the evaluation of tSMS in larger and more prolonged studies.
