Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
NCT06681610

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

Led by Parc de Salut Mar · Updated on 2024-11-08

50

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of sporadic ALS (definite or clinically probable) according to revised El Escorial criteria
  • Forced vital capacity (SVC) of 50% or greater of estimated measure
  • Presence of measurable motor evoked potentials
  • Age between 21 and 80 years
  • Male or female gender
Not Eligible

You will not qualify if you...

  • Familial ALS patients unable to tolerate TMS and MRI studies
  • Contraindications to TMS or MRI as described by the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital del Mar

Barcelona, Catalonia, Spain, 08003

Actively Recruiting

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Research Team

A

Alba Leon, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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