Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Hospital del Mar
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
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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