Pulse Stimulation of the Brain Studied in People With ALS
Tests brain pulse stimulation device against sham treatment in adults with ALS.
Plain-language title generated from the registry record
Registry title: Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 80 years old?
Source: NCT06681610, who can take part
Where in Spain
- Hospital del MarBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Parc de Salut Mar
- Trial code
- NCT06681610
- Record updated
- 8 November 2024
- Original description
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:Read full original descriptionShow less
Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial
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
Inclusion: 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.
Exclusion: patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below.