QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up

Amyotrophic Lateral Sclerosis Clinical Trial

— PEM-SLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284161
• Other study ID #: RBHP 2020 GUY
• Secondary ID: 2020-A02765-34
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2026
• Est. primary completion date: June 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Quadriceps 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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters from the QCT (Quadriceps Combined Test)	Measure of amplitude of M	At inclusion
Primary	Parameters from the QCT (Quadriceps Combined Test)	Measure of amplitude of M	Month 6
Primary	Parameters from the QCT (Quadriceps Combined Test)	Measure of amplitude of M	Month 12
Primary	Parameters from the QCT (Quadriceps Combined Test)	Measure of amplitude of M	month 18
Primary	Parameters from the QCT (Quadriceps Combined Test)	Measure of amplitude of M	month 24
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCP response,	At inclusion
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCP response,	month 6
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCP response,	month 12
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCP response,	month 18
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCP response,	month 24
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCC response	At inclusion
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCC response	month 6
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCC response	month 12
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCC response	month 18
Primary	Parameters from the QCT (Quadriceps Combined Test)	measure of TCC response	month 24
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of amplitude	At inclusion
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of amplitude	month 6
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of amplitude	month 12
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of amplitude	month 18
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of amplitude	month 24
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP latency ratio	At inclusion
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP latency ratio	month 6
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP latency ratio	month 12
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP latency ratio	month 18
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP latency ratio	month 24
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP amplitude ratio.	At inclusion
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP amplitude ratio.	month 6
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP amplitude ratio.	month 12
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP amplitude ratio.	month 18
Primary	Parameters from the QCT (Quadriceps Combined Test)	ratio calculation of T/MEP amplitude ratio.	month 24
Secondary	Clinical and paraclinical likely course data	MRC (Medical Research Council) scale for the evaluation of muscular strength	At inclusion
Secondary	Clinical and paraclinical likely course data	ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.	At inclusion
Secondary	Clinical and paraclinical likely course data	Spirometry data : Slow Vital Capacity	At inclusion
Secondary	Clinical and paraclinical likely course data	Spirometry data : Maximal Inspiratory Pressure	At inclusion
Secondary	Clinical and paraclinical likely course data	Spirometry data : Maximal Exhalation Pressure	At inclusion
Secondary	Clinical and paraclinical likely course data	Weight	At inclusion
Secondary	Clinical and paraclinical likely course data	Percentage of weight loss	At inclusion
Secondary	Clinical and paraclinical likely course data	Oxymetry	At inclusion
Secondary	Clinical and paraclinical likely course data	Non-Invasive Ventilation implementation (yes or no)	At inclusion
Secondary	Clinical and paraclinical likely course data	Gastrostomy implementation (yes or no)	At inclusion
Secondary	Clinical and paraclinical likely course data	Survival	At inclusion
Secondary	Clinical and paraclinical likely course data	MRC scale for the evaluation of muscular strength	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	ALSFRS-R score	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Spirometry data : Slow Vital Capacity	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Spirometry data : Maximal Inspiratory Pressure	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Spirometry data : Maximal Exhalation Pressure	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Weight	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Percentage of weight loss	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Oximetry	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Non-Invasive Ventilation Implementation (yes or no)	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Gastrostomy implementation (yes or no)	Every 3 months up to 2 years
Secondary	Clinical and paraclinical likely course data	Survival	Every 3 months up to 2 years