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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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

Key facts

Study ID

NCT06681610

Run by

Parc de Salut Mar

People needed

50

Starts

2024-10-24

Expected to finish

2026-12-01

Last updated by the study team

2024-11-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below

Where it is running

• Hospital del Mar — Barcelona, Catalonia, Spain (enrolling)

Full record on ClinicalTrials.gov

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