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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
tSMS delivered on bilateral motor cortex
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
Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS
Milan, Italy
RECRUITINGNeurology Unit, Campus Biomedico University
Rome, Italy
RECRUITINGDisease 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.
Time frame: 9 months
Safety and tolerability
Incidence of adverse events during the stimulation period
Time frame: 6 months
Compliance
Number of stimulation sessions actually completed by each patient
Time frame: 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.
Time frame: 6 months
Effect on motor evoked potentials (MEP) size
Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
Time frame: 6 months
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