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NCT Number: NCT06681610

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

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location status: Recruiting

Location contact

Alba Leon, MD

PRINCIPAL_INVESTIGATOR

Sergio Vidal, MD

CONTACT

[email protected]

+34932 48 30 00

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Pulse Stimulation

Device

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

Primary outcomes

  1. Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.

    Time frame: baseline to week 8

  2. Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score

    Time frame: baseline to week 24

    The ALS Functional Rating Scale-Revised Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.

    Higher scores mean a better outcome.

Secondary outcomes

  1. Change plasma neurofilament light chain (NfL) levels

    Time frame: baseline to week 4 and 8

  2. Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score

    Time frame: baseline to week 4 and 8

  3. Changes in hand-held dynamometry

    Time frame: baseline to week 8

  4. Differences (treated vs sham) and change in the slow vital capacity (SVC)

    Time frame: from baseline to month 6

  5. Differences (treated vs sham) and change in plasma NfL levels

    Time frame: baseline to month 6

    Candidate biomarkers are: SOD1, Ataxin 2, C90rf72, UNC13A, TDP43, stathmin 2, NfL and NfH levels

  6. Change in Motor Evoked Potential (MEP) Amplitudes

    Time frame: baseline to week 4 and 8

    ppTMS will be used to assess changes in motor cortex excitability via MEP amplitude (measured in millivolts)

  7. Change in Resting Motor Threshold

    Time frame: baseline to week 4 and 8

    RMT will be recorded to assess baseline motor cortex excitability (measured as a percentage of maximum stimulator output)

  8. Change in Intra-Cortical Facilitation

    Time frame: baseline to week 4 and 8

    ICF will be measured to assess synaptic excitability

Other outcomes

  1. Change in biomarker SOD1 Levels in nEVs from Plasma

    Time frame: baseline to week 4 and 8

  2. Change in biomarker Ataxin 2 Levels in nEVs from Plasma

    Time frame: baseline to week 4 and 8

  3. Change in biomarker C9orf72 Levels in nEVs from Plasma

    Time frame: baseline to week 4 and 8

  4. Change in biomarker UNC13A Levels in nEVs from Plasma

    Time frame: baseline to week 4 and 8

  5. Change in biomarker TDP43 Levels in nEVs from Plasma

    Time frame: baseline to week 4 and 8

  6. Change in biomarker Stathmin 2 Levels in nEVs from Plasma

    Time frame: baseline to week 4 and 8

  7. Change in NfH Levels in nEVs from Plasma

    Time frame: baseline to week 4 and 8

Study contacts

Contact information is provided by the study sponsor or research team.

Alba Leon, MD

CONTACT

[email protected]

+34932 48 30 00

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: TPS4ALS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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