RecruitingRecruiting
Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study
NCT06681610 · Parc de Salut Mar
In plain English
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Official title
Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial
About this study
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
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-10-24
Estimated completion: 2026-12
Last updated: 2024-11-08
Interventions
Device: Transcranial Pulse Stimulation
Primary outcomes
- • Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8. (baseline to week 8)
- • Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score (baseline to week 24)
Sponsor
Parc de Salut Mar · other
Contacts & investigators
ContactAlba Leon, MD · contact · aleonjorba@psmar.cat · +34932 48 30 00
All locations (1)
Hospital del MarRecruiting
Barcelona, Catalonia, Spain