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

NCT06681610 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-08

No results posted yet for this study

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

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DEVICE

Transcranial Pulse Stimulation

low intensity shock-waves stimulation of the motor cortex, bilateral

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2025-04-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06681610 on ClinicalTrials.gov