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NCT Number: NCT06284161

QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up

Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.

The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.

The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis.

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Key information

Conditions

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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location status: Recruiting

Location contact

Lise Laclautre

CONTACT

[email protected]

+33473754963

Nathalie Guy

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A male or female patient of legal age with suspected ALS (bulbar or spinal) who meets the criteria for "possible", "probable" or "definite" ALS according to the Awaji criteria
  • Able to give informed consent to participate in the research
  • Enrolled in a Social Security plan

Exclusion criteria

  • Pregnant or breastfeeding woman
  • Severe progressive pathology other than ALS.
  • Comorbidities with another neurological disease altering motor skills.
  • Contraindication to trans-cranial magnetic stimulation: epilepsy, pacemaker, intracranial ferromagnetic foreign body (clip, aneurysm, implants)...
  • Chronic alcoholism
  • Cognitive disorders or major incapacity making it impossible to understand the study and sign an informed consent (fronto-temporal dementia, psychiatric conditions of psychotic type, language disorders)
  • Refusal to participate.
  • Patients under legal protection (guardianship, curators, safeguard of justice)

Treatment and study plan

Quadriceps Combined Test

Diagnostic Test

The recording of the motor response on the quadriceps is done using self-adhesive surface electrodes on the motor point of the vastus medialis muscles (active electrodes) and on the patella (reference electrode), using a classic electromyography device that allows calculations and measurements of amplitude, duration and speed.

Other names: Motor- Evoked Potentials

Primary outcomes

  1. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: At inclusion

    Measure of amplitude of M

  2. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: Month 6

    Measure of amplitude of M

  3. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: Month 12

    Measure of amplitude of M

  4. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 18

    Measure of amplitude of M

  5. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 24

    Measure of amplitude of M

  6. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: At inclusion

    measure of TCP response,

  7. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 6

    measure of TCP response,

  8. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 12

    measure of TCP response,

  9. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 18

    measure of TCP response,

  10. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 24

    measure of TCP response,

  11. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: At inclusion

    measure of TCC response

  12. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 6

    measure of TCC response

  13. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 12

    measure of TCC response

  14. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 18

    measure of TCC response

  15. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 24

    measure of TCC response

  16. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: At inclusion

    ratio calculation of amplitude

  17. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 6

    ratio calculation of amplitude

  18. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 12

    ratio calculation of amplitude

  19. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 18

    ratio calculation of amplitude

  20. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 24

    ratio calculation of amplitude

  21. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: At inclusion

    ratio calculation of T/MEP latency ratio

  22. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 6

    ratio calculation of T/MEP latency ratio

  23. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 12

    ratio calculation of T/MEP latency ratio

  24. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 18

    ratio calculation of T/MEP latency ratio

  25. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 24

    ratio calculation of T/MEP latency ratio

  26. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: At inclusion

    ratio calculation of T/MEP amplitude ratio.

  27. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 6

    ratio calculation of T/MEP amplitude ratio.

  28. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 12

    ratio calculation of T/MEP amplitude ratio.

  29. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 18

    ratio calculation of T/MEP amplitude ratio.

  30. Parameters from the QCT (Quadriceps Combined Test)

    Time frame: month 24

    ratio calculation of T/MEP amplitude ratio.

Secondary outcomes

  1. Clinical and paraclinical likely course data

    Time frame: At inclusion

    MRC (Medical Research Council) scale for the evaluation of muscular strength. Score from 0 to 5. Higher score means normal movement

  2. Clinical and paraclinical likely course data

    Time frame: At inclusion

    ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.

  3. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Spirometry data : Slow Vital Capacity

  4. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Spirometry data : Maximal Inspiratory Pressure

  5. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Spirometry data : Maximal Exhalation Pressure

  6. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Weight

  7. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Percentage of weight loss

  8. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Oxymetry

  9. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Non-Invasive Ventilation implementation (yes or no)

  10. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Gastrostomy implementation (yes or no)

  11. Clinical and paraclinical likely course data

    Time frame: At inclusion

    Survival

  12. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    MRC (Medical Research Council) scale for the evaluation of muscular strength. Score from 0 to 5. Higher score means normal movement

  13. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.

  14. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Spirometry data : Slow Vital Capacity

  15. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Spirometry data : Maximal Inspiratory Pressure

  16. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Spirometry data : Maximal Exhalation Pressure

  17. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Weight

  18. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Percentage of weight loss

  19. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Oximetry

  20. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Non-Invasive Ventilation Implementation (yes or no)

  21. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Gastrostomy implementation (yes or no)

  22. Clinical and paraclinical likely course data

    Time frame: Every 3 months up to 2 years

    Survival

Study contacts

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

Lise LACLAUTRE

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Contribution of the Combined Quadriceps Test (QCT) in the Diagnosis, Mechanistic Understanding and Follow-up of Amyotrophic Lateral Sclerosis

Acronym: PEM-SLA

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
Feb 28, 2024
Registry last updated
Jul 30, 2026

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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