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RECRUITINGINTERVENTIONAL

Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study

Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below

Treatments Being Tested

DEVICE

Transcranial Pulse Stimulation

low intensity shock-waves stimulation of the motor cortex, bilateral

Locations (1)

Hospital del Mar
Barcelona, Catalonia, Spain