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

Last updated: November 7, 2024
Sponsor: Parc de Salut Mar
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Scar Tissue

Treatment

Transcranial Pulse Stimulation

Clinical Study ID

NCT06681610
NEU-TPS-ALS-01
FUSF-RAP-S-23-00096
  • Ages 21-80
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with diagnosis of sporadic ALS (definite or clinically probable) as definedby the World Federation of Neurology revised El Escorial criteria

  • SVC of 50% or greater of estimated measure and presence of measurable motor evokedpotential

  • 21 to 80 years old and male or female

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Transcranial Pulse Stimulation
Phase:
Study Start date:
October 24, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Hospital del Mar

    Barcelona, Catalonia 08003
    Spain

    Active - Recruiting

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