The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:
* Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8? * Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?
In stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score
Participants will receive either:
* the TPS treatment * a sham TPS treatment
Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria
SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential
21 to 80 years old and male or female
patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below
Parallel
Transcranial Pulse Stimulation
Devicelow intensity shock-waves stimulation of the motor cortex, bilateral
Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.
Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score
The ALS Functional Rating Scale-Revised Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Higher scores mean a better outcome.
Change plasma neurofilament light chain (NfL) levels
Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score
Changes in hand-held dynamometry
Differences (treated vs sham) and change in the slow vital capacity (SVC)
Change in biomarker SOD1 Levels in nEVs from Plasma
Change in biomarker Ataxin 2 Levels in nEVs from Plasma
Change in biomarker C9orf72 Levels in nEVs from Plasma
Change in biomarker UNC13A Levels in nEVs from Plasma
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