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RECRUITING
NCT06681610
NA

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

Sponsor: Parc de Salut Mar

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-10-24

Completion Date

2026-12

Last Updated

2024-11-08

Healthy Volunteers

No

Interventions

DEVICE

Transcranial Pulse Stimulation

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

Locations (1)

Hospital del Mar

Barcelona, Catalonia, Spain