Amyotrophic Lateral SclerosisPEM-SLANCT06284161
QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up
A study testing Quadriceps Combined Test in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Quadriceps Combined Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2022to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Nathalie Guy
About this study
Official title: Contribution of the Combined Quadriceps Test (QCT) in the Diagnosis, Mechanistic Understanding and Follow-up of Amyotrophic Lateral Sclerosis
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Quadriceps Combined Test
- Keywords
- Quadriceps Combined Test, Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps Combined TestDiagnostic test
Also called Motor- Evoked Potentials
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.
| Study group | Role | What they receive |
|---|---|---|
| Quadriceps Combined Test | Other | Not described Receives: Diagnostic Test: Quadriceps Combined Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters from the QCT (Quadriceps Combined Test)
Measure of amplitude of M
Measured: At inclusion
Parameters from the QCT (Quadriceps Combined Test)
Measure of amplitude of M
Measured: Month 6
Parameters from the QCT (Quadriceps Combined Test)
Measure of amplitude of M
Measured: Month 12
Parameters from the QCT (Quadriceps Combined Test)
Measure of amplitude of M
Measured: month 18
Parameters from the QCT (Quadriceps Combined Test)
Measure of amplitude of M
Measured: month 24
Parameters from the QCT (Quadriceps Combined Test)
measure of TCP response,
Measured: At inclusion
Parameters from the QCT (Quadriceps Combined Test)
measure of TCP response,
Measured: month 6
Parameters from the QCT (Quadriceps Combined Test)
measure of TCP response,
Measured: month 12
Parameters from the QCT (Quadriceps Combined Test)
measure of TCP response,
Measured: month 18
Parameters from the QCT (Quadriceps Combined Test)
measure of TCP response,
Measured: month 24
Parameters from the QCT (Quadriceps Combined Test)
measure of TCC response
Measured: At inclusion
Parameters from the QCT (Quadriceps Combined Test)
measure of TCC response
Measured: month 6
Parameters from the QCT (Quadriceps Combined Test)
measure of TCC response
Measured: month 12
Parameters from the QCT (Quadriceps Combined Test)
measure of TCC response
Measured: month 18
Parameters from the QCT (Quadriceps Combined Test)
measure of TCC response
Measured: month 24
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of amplitude
Measured: At inclusion
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of amplitude
Measured: month 6
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of amplitude
Measured: month 12
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of amplitude
Measured: month 18
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of amplitude
Measured: month 24
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP latency ratio
Measured: At inclusion
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP latency ratio
Measured: month 6
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP latency ratio
Measured: month 12
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP latency ratio
Measured: month 18
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP latency ratio
Measured: month 24
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP amplitude ratio.
Measured: At inclusion
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP amplitude ratio.
Measured: month 6
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP amplitude ratio.
Measured: month 12
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP amplitude ratio.
Measured: month 18
Parameters from the QCT (Quadriceps Combined Test)
ratio calculation of T/MEP amplitude ratio.
Measured: month 24
Secondary outcomes (22)
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
Measured: At inclusion
Clinical and paraclinical likely course data
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.
Measured: At inclusion
Clinical and paraclinical likely course data
Spirometry data : Slow Vital Capacity
Measured: At inclusion
Clinical and paraclinical likely course data
Spirometry data : Maximal Inspiratory Pressure
Measured: At inclusion
Clinical and paraclinical likely course data
Spirometry data : Maximal Exhalation Pressure
Measured: At inclusion
Clinical and paraclinical likely course data
Weight
Measured: At inclusion
Clinical and paraclinical likely course data
Percentage of weight loss
Measured: At inclusion
Clinical and paraclinical likely course data
Oxymetry
Measured: At inclusion
Clinical and paraclinical likely course data
Non-Invasive Ventilation implementation (yes or no)
Measured: At inclusion
Clinical and paraclinical likely course data
Gastrostomy implementation (yes or no)
Measured: At inclusion
Clinical and paraclinical likely course data
Survival
Measured: At inclusion
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
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Spirometry data : Slow Vital Capacity
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Spirometry data : Maximal Inspiratory Pressure
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Spirometry data : Maximal Exhalation Pressure
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Weight
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Percentage of weight loss
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Oximetry
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Non-Invasive Ventilation Implementation (yes or no)
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Gastrostomy implementation (yes or no)
Measured: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Survival
Measured: Every 3 months up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Jun 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Guy, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284161
- Sponsor's protocol ID
- RBHP 2020 GUY
- Other IDs
- 2020-A02765-34
- Acronym
- PEM-SLA
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2022
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Combined Quadriceps Test (QCT) in the Diagnosis, Mechanistic Understanding and Follow-up of Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06284161
- Acronym / sponsor ID
- PEM-SLA / RBHP 2020 GUY
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Quadriceps Combined Test, Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadriceps Combined Test | Other | Diagnostic Test: Quadriceps Combined Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadriceps Combined TestAlso: Motor- Evoked PotentialsThe 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. | Diagnostic test | Quadriceps Combined Test |
Primary outcome
Parameters from the QCT (Quadriceps Combined Test)
Time frame: At inclusion
Measure of amplitude of M
Parameters from the QCT (Quadriceps Combined Test)
Time frame: Month 6
Measure of amplitude of M
Parameters from the QCT (Quadriceps Combined Test)
Time frame: Month 12
Measure of amplitude of M
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 18
Measure of amplitude of M
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 24
Measure of amplitude of M
Parameters from the QCT (Quadriceps Combined Test)
Time frame: At inclusion
measure of TCP response,
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 6
measure of TCP response,
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 12
measure of TCP response,
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 18
measure of TCP response,
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 24
measure of TCP response,
Parameters from the QCT (Quadriceps Combined Test)
Time frame: At inclusion
measure of TCC response
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 6
measure of TCC response
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 12
measure of TCC response
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 18
measure of TCC response
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 24
measure of TCC response
Parameters from the QCT (Quadriceps Combined Test)
Time frame: At inclusion
ratio calculation of amplitude
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 6
ratio calculation of amplitude
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 12
ratio calculation of amplitude
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 18
ratio calculation of amplitude
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 24
ratio calculation of amplitude
Parameters from the QCT (Quadriceps Combined Test)
Time frame: At inclusion
ratio calculation of T/MEP latency ratio
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 6
ratio calculation of T/MEP latency ratio
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 12
ratio calculation of T/MEP latency ratio
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 18
ratio calculation of T/MEP latency ratio
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 24
ratio calculation of T/MEP latency ratio
Parameters from the QCT (Quadriceps Combined Test)
Time frame: At inclusion
ratio calculation of T/MEP amplitude ratio.
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 6
ratio calculation of T/MEP amplitude ratio.
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 12
ratio calculation of T/MEP amplitude ratio.
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 18
ratio calculation of T/MEP amplitude ratio.
Parameters from the QCT (Quadriceps Combined Test)
Time frame: month 24
ratio calculation of T/MEP amplitude ratio.
22 secondary outcomes
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: At inclusion
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Clinical and paraclinical likely course data
Time frame: Every 3 months up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie Guy principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps Combined Test in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters from the QCT (Quadriceps Combined Test) (time frame: At inclusion). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.