QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up

NCT06284161 | Recruiting

• 2 other identifiers: RBHP 2020 GUY2020-A02765-34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Quadriceps Combined Test; Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (30)

• Parameters from the QCT (Quadriceps Combined Test)

  Measure of amplitude of M

  At inclusion

• Parameters from the QCT (Quadriceps Combined Test)

  Measure of amplitude of M

  Month 6

• Parameters from the QCT (Quadriceps Combined Test)

  Measure of amplitude of M

  Month 12

• Parameters from the QCT (Quadriceps Combined Test)

  Measure of amplitude of M

  month 18

• Parameters from the QCT (Quadriceps Combined Test)

  Measure of amplitude of M

  month 24

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCP response,

  At inclusion

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCP response,

  month 6

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCP response,

  month 12

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCP response,

  month 18

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCP response,

  month 24

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCC response

  At inclusion

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCC response

  month 6

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCC response

  month 12

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCC response

  month 18

• Parameters from the QCT (Quadriceps Combined Test)

  measure of TCC response

  month 24

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of amplitude

  At inclusion

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of amplitude

  month 6

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of amplitude

  month 12

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of amplitude

  month 18

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of amplitude

  month 24

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP latency ratio

  At inclusion

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP latency ratio

  month 6

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP latency ratio

  month 12

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP latency ratio

  month 18

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP latency ratio

  month 24

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP amplitude ratio.

  At inclusion

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP amplitude ratio.

  month 6

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP amplitude ratio.

  month 12

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP amplitude ratio.

  month 18

• Parameters from the QCT (Quadriceps Combined Test)

  ratio calculation of T/MEP amplitude ratio.

  month 24

Secondary Outcomes (22)

• Clinical and paraclinical likely course data

  At inclusion

• Clinical and paraclinical likely course data

  At inclusion

• Clinical and paraclinical likely course data

  At inclusion

• Clinical and paraclinical likely course data

  At inclusion

• Clinical and paraclinical likely course data

  At inclusion

Study Arms (1)

Quadriceps Combined Test

OTHER

Diagnostic Test: Quadriceps Combined Test

Interventions

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.

Also known as: Motor- Evoked Potentials

Quadriceps Combined Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Evoked Potentials, Motor

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nathalie Guy

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: February 28, 2024
• Study Start: June 28, 2022
• Primary Completion: June 28, 2025
• Study Completion: February 28, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-02

Locations

FR (1)