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Recruiting NCT06681610

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

No phase Interventional Amyotrophic Lateral Sclerosis (ALS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Pulse Stimulation.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis (ALS). Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device Transcranial Pulse Stimulation
    low intensity shock-waves stimulation of the motor cortex, bilateral

Primary outcome measures

  • Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8. [Time frame: baseline to week 8]
  • Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score [Time frame: baseline to week 24]
Secondary outcome measures (8)
  • Change plasma neurofilament light chain (NfL) levels [Time frame: baseline to week 4 and 8]
  • Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score [Time frame: baseline to week 4 and 8]
  • Changes in hand-held dynamometry [Time frame: baseline to week 8]
  • Differences (treated vs sham) and change in the slow vital capacity (SVC) [Time frame: from baseline to month 6]
  • Differences (treated vs sham) and change in plasma NfL levels [Time frame: baseline to month 6]
  • Change in Motor Evoked Potential (MEP) Amplitudes [Time frame: baseline to week 4 and 8]
  • Change in Resting Motor Threshold [Time frame: baseline to week 4 and 8]
  • Change in Intra-Cortical Facilitation [Time frame: baseline to week 4 and 8]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital del Mar — Barcelona

Publications

  • Voroslakos M, Takeuchi Y, Brinyiczki K, Zombori T, Oliva A, Fernandez-Ruiz A, Kozak G, Kincses ZT, Ivanyi B, Buzsaki G, Berenyi A. Direct effects of transcranial electric stimulation on brain circuits in rats and humans. Nat Commun. 2018 Feb 2;9(1):483. doi: 10.1038/s41467-018-02928-3. PMID 29396478
  • Kim HC, Lee W, Kunes J, Yoon K, Lee JE, Foley L, Kowsari K, Yoo SS. Transcranial focused ultrasound modulates cortical and thalamic motor activity in awake sheep. Sci Rep. 2021 Sep 29;11(1):19274. doi: 10.1038/s41598-021-98920-x. PMID 34588588
  • Feldman EL, Goutman SA, Petri S, Mazzini L, Savelieff MG, Shaw PJ, Sobue G. Amyotrophic lateral sclerosis. Lancet. 2022 Oct 15;400(10360):1363-1380. doi: 10.1016/S0140-6736(22)01272-7. Epub 2022 Sep 15. PMID 36116464

Identifiers

NCT: NCT06681610 · NEU-TPS-ALS-01 · FUSF-RAP-S-23-00096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗