NCT06681610Recruiting
Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study
Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 6 Nov 2024
- Start date
- 24 Oct 2024
- Primary completion date
- Apr 2025
- Lead sponsor
- Parc de Salut Mar
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06681610
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 24 Oct 2024 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below
Who the study is looking for
- 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
Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.