NCT06681610 Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study
| NCT ID | NCT06681610 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Parc de Salut Mar |
| Condition | Amyotrophic Lateral Sclerosis (ALS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-10-24 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * 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 Criteria: * patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06681610 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Amyotrophic Lateral Sclerosis (ALS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06681610 currently recruiting?
Yes, NCT06681610 is actively recruiting participants. Contact the research team at aleonjorba@psmar.cat for enrollment information.
Where is the NCT06681610 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06681610 clinical trial?
NCT06681610 is sponsored by Parc de Salut Mar. The trial plans to enroll 50 participants.
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