Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study (TPS4ALS)

Parc de Salut Mar

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Device: Transcranial Pulse Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06681610

NEU-TPS-ALS-01

FUSF-RAP-S-23-00096 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

TPS

Experimental group

Description:

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.

Treatment:

Device: Transcranial Pulse Stimulation

sham

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Pulse Stimulation