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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02765-34 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadriceps Combined Test | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Description | Time Frame |
|---|---|---|
| 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 | At inclusion |
| Clinical and paraclinical likely course data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie Guy | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D019054 | Evoked Potentials, Motor |
| ID | Term |
|---|---|
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
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|
|
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 |
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.
| At inclusion |
| Clinical and paraclinical likely course data | Spirometry data : Slow Vital Capacity | At inclusion |
| Clinical and paraclinical likely course data | Spirometry data : Maximal Inspiratory Pressure | At inclusion |
| Clinical and paraclinical likely course data | Spirometry data : Maximal Exhalation Pressure | At inclusion |
| Clinical and paraclinical likely course data | Weight | At inclusion |
| Clinical and paraclinical likely course data | Percentage of weight loss | At inclusion |
| Clinical and paraclinical likely course data | Oxymetry | At inclusion |
| Clinical and paraclinical likely course data | Non-Invasive Ventilation implementation (yes or no) | At inclusion |
| Clinical and paraclinical likely course data | Gastrostomy implementation (yes or no) | At inclusion |
| Clinical and paraclinical likely course data | Survival | 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 | 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. | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Spirometry data : Slow Vital Capacity | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Spirometry data : Maximal Inspiratory Pressure | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Spirometry data : Maximal Exhalation Pressure | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Weight | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Percentage of weight loss | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Oximetry | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Non-Invasive Ventilation Implementation (yes or no) | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Gastrostomy implementation (yes or no) | Every 3 months up to 2 years |
| Clinical and paraclinical likely course data | Survival | Every 3 months up to 2 years |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |