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Recruiting NCT06681610

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

Trial Parameters

Condition Amyotrophic Lateral Sclerosis (ALS)
Sponsor Parc de Salut Mar
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 21 Years
Max Age 80 Years
Start Date 2024-10-24
Completion 2025-04
Interventions
Transcranial Pulse Stimulation

Brief Summary

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

Eligibility Criteria

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

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