Improving motor function in ALS patients using pulse stimulation
Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial
This study is testing if a new brain stimulation treatment can improve movement and daily function in people with ALS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Parc de Salut Mar Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT06681610 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Transcranial Pulse Stimulation (TPS) on motor function in individuals diagnosed with Amyotrophic Lateral Sclerosis (ALS). The study is divided into two stages: the first stage assesses changes in short intracortical inhibition of the motor cortex over eight weeks, while the second stage compares the effects of TPS versus sham stimulation on the ALS functional rating scale over six months. Participants will be monitored for changes in biomarkers and clinical endpoints to determine the efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 21 to 80 with a diagnosis of sporadic ALS who meet specific clinical criteria.
Not a fit: Patients with familial ALS or those unable to tolerate TMS and MRI studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance motor function and quality of life for patients with ALS.
How similar studies have performed: While this approach is innovative, similar studies using non-invasive brain stimulation techniques have shown promise in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona, Catalonia
- Hospital del Mar — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Study coordinator: Alba Leon, MD
- Email: aleonjorba@psmar.cat
- Phone: +34932 48 30 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.