Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital del Mar
RECRUITING
Barcelona
Contact Information
Primary
Alba Leon, MD
aleonjorba@psmar.cat
+34932 48 30 00
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2026-12
Participants
Target number of participants: 50
Treatments
Experimental: TPS
The stimulation will be 20 min duration as indicated in the CE mark approval. Each session involves 6,000 pulses in the hand region of the motor cortex with 3,000 on each side of the brain. The system uses a low energy flux density maximum of 0.25 mJ/mm2 accordingly with EMA and FDA guidelines (high energy is defined as \> 0.5 mJ/mm2). The standard therapy involves 6 sessions in 2 weeks as indicated in the CE mark.
Sham_comparator: sham
The transcranial pulse stimulation with the same device and the same protocol uses a membrane on the device that blocks the sound waves. Participants' motor cortex is not stimulated.
Sponsors
Leads: Parc de Salut Mar

This content was sourced from clinicaltrials.gov