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RecruitingNCT06284161PEM-SLAUpdated Jul 30, 2026

QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up

An interventional study of Quadriceps Combined Test in Amyotrophic Lateral Sclerosis, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Quadriceps Combined Test
  • Amyotrophic Lateral Sclerosis
03

In context

Amyotrophic Lateral Sclerosis

981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 283 are open to participants now.

This study's planned enrollment of 30 is below the median of 36 across 667 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Quadriceps Combined Test

    Diagnostic Test: Quadriceps Combined Test

Interventions

  • Diagnostic testQuadriceps Combined 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.

    Also known as: Motor- Evoked Potentials

06

What researchers measure

Primary outcomes

  1. Parameters from the QCT (Quadriceps Combined Test)

    Measure of amplitude of M

    Time frame: At inclusion

  2. Parameters from the QCT (Quadriceps Combined Test)

    Measure of amplitude of M

    Time frame: Month 6

  3. Parameters from the QCT (Quadriceps Combined Test)

    Measure of amplitude of M

    Time frame: Month 12

  4. Parameters from the QCT (Quadriceps Combined Test)

    Measure of amplitude of M

    Time frame: month 18

  5. Parameters from the QCT (Quadriceps Combined Test)

    Measure of amplitude of M

    Time frame: month 24

  6. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCP response,

    Time frame: At inclusion

  7. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCP response,

    Time frame: month 6

  8. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCP response,

    Time frame: month 12

  9. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCP response,

    Time frame: month 18

  10. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCP response,

    Time frame: month 24

  11. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCC response

    Time frame: At inclusion

  12. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCC response

    Time frame: month 6

  13. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCC response

    Time frame: month 12

  14. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCC response

    Time frame: month 18

  15. Parameters from the QCT (Quadriceps Combined Test)

    measure of TCC response

    Time frame: month 24

  16. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of amplitude

    Time frame: At inclusion

  17. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of amplitude

    Time frame: month 6

  18. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of amplitude

    Time frame: month 12

  19. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of amplitude

    Time frame: month 18

  20. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of amplitude

    Time frame: month 24

  21. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP latency ratio

    Time frame: At inclusion

  22. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP latency ratio

    Time frame: month 6

  23. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP latency ratio

    Time frame: month 12

  24. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP latency ratio

    Time frame: month 18

  25. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP latency ratio

    Time frame: month 24

  26. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP amplitude ratio.

    Time frame: At inclusion

  27. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP amplitude ratio.

    Time frame: month 6

  28. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP amplitude ratio.

    Time frame: month 12

  29. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP amplitude ratio.

    Time frame: month 18

  30. Parameters from the QCT (Quadriceps Combined Test)

    ratio calculation of T/MEP amplitude ratio.

    Time frame: month 24

Secondary outcomes

  1. Clinical and paraclinical likely course data

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

    Time frame: At inclusion

  2. Clinical and paraclinical likely course data

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

    Time frame: At inclusion

  3. Clinical and paraclinical likely course data

    Spirometry data : Slow Vital Capacity

    Time frame: At inclusion

  4. Clinical and paraclinical likely course data

    Spirometry data : Maximal Inspiratory Pressure

    Time frame: At inclusion

  5. Clinical and paraclinical likely course data

    Spirometry data : Maximal Exhalation Pressure

    Time frame: At inclusion

  6. Clinical and paraclinical likely course data

    Weight

    Time frame: At inclusion

  7. Clinical and paraclinical likely course data

    Percentage of weight loss

    Time frame: At inclusion

  8. Clinical and paraclinical likely course data

    Oxymetry

    Time frame: At inclusion

  9. Clinical and paraclinical likely course data

    Non-Invasive Ventilation implementation (yes or no)

    Time frame: At inclusion

  10. Clinical and paraclinical likely course data

    Gastrostomy implementation (yes or no)

    Time frame: At inclusion

  11. Clinical and paraclinical likely course data

    Survival

    Time frame: At inclusion

  12. Clinical and paraclinical likely course data

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

    Time frame: Every 3 months up to 2 years

  13. Clinical and paraclinical likely course data

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

    Time frame: Every 3 months up to 2 years

  14. Clinical and paraclinical likely course data

    Spirometry data : Slow Vital Capacity

    Time frame: Every 3 months up to 2 years

  15. Clinical and paraclinical likely course data

    Spirometry data : Maximal Inspiratory Pressure

    Time frame: Every 3 months up to 2 years

  16. Clinical and paraclinical likely course data

    Spirometry data : Maximal Exhalation Pressure

    Time frame: Every 3 months up to 2 years

  17. Clinical and paraclinical likely course data

    Weight

    Time frame: Every 3 months up to 2 years

  18. Clinical and paraclinical likely course data

    Percentage of weight loss

    Time frame: Every 3 months up to 2 years

  19. Clinical and paraclinical likely course data

    Oximetry

    Time frame: Every 3 months up to 2 years

  20. Clinical and paraclinical likely course data

    Non-Invasive Ventilation Implementation (yes or no)

    Time frame: Every 3 months up to 2 years

  21. Clinical and paraclinical likely course data

    Gastrostomy implementation (yes or no)

    Time frame: Every 3 months up to 2 years

  22. Clinical and paraclinical likely course data

    Survival

    Time frame: Every 3 months up to 2 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06284161
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Feb 28, 2024
Start date
Jun 28, 2022
Primary completion
Jun 2028 (estimated)
Completion
Jun 2030 (estimated)
Last update
Jul 30, 2026

Study contacts

Lise LACLAUTRE
Contact
promo_interne_drci@chu-clermontferrand.fr
+33473754963
Nathalie Guy
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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