Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2025-12-27 @ 9:33 PM
Study NCT ID:
NCT06284161
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2022-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019054', 'term': 'Evoked Potentials, Motor'}], 'ancestors': [{'id': 'D005071', 'term': 'Evoked Potentials'}, {'id': 'D000071080', 'term': 'Cortical Excitability'}, {'id': 'D055724', 'term': 'Electrophysiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'At inclusion', 'description': 'Measure of amplitude of M'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'Month 6', 'description': 'Measure of amplitude of M'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'Month 12', 'description': 'Measure of amplitude of M'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 18', 'description': 'Measure of amplitude of M'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 24', 'description': 'Measure of amplitude of M'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'At inclusion', 'description': 'measure of TCP response,'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 6', 'description': 'measure of TCP response,'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 12', 'description': 'measure of TCP response,'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 18', 'description': 'measure of TCP response,'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 24', 'description': 'measure of TCP response,'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'At inclusion', 'description': 'measure of TCC response'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 6', 'description': 'measure of TCC response'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 12', 'description': 'measure of TCC response'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 18', 'description': 'measure of TCC response'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 24', 'description': 'measure of TCC response'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'At inclusion', 'description': 'ratio calculation of amplitude'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 6', 'description': 'ratio calculation of amplitude'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 12', 'description': 'ratio calculation of amplitude'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 18', 'description': 'ratio calculation of amplitude'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 24', 'description': 'ratio calculation of amplitude'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'At inclusion', 'description': 'ratio calculation of T/MEP latency ratio'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 6', 'description': 'ratio calculation of T/MEP latency ratio'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 12', 'description': 'ratio calculation of T/MEP latency ratio'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 18', 'description': 'ratio calculation of T/MEP latency ratio'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 24', 'description': 'ratio calculation of T/MEP latency ratio'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'At inclusion', 'description': 'ratio calculation of T/MEP amplitude ratio.'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 6', 'description': 'ratio calculation of T/MEP amplitude ratio.'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 12', 'description': 'ratio calculation of T/MEP amplitude ratio.'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 18', 'description': 'ratio calculation of T/MEP amplitude ratio.'}, {'measure': 'Parameters from the QCT (Quadriceps Combined Test)', 'timeFrame': 'month 24', 'description': 'ratio calculation of T/MEP amplitude ratio.'}], 'secondaryOutcomes': [{'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'MRC (Medical Research Council) scale for the evaluation of muscular strength. Score from 0 to 5. Higher score means normal movement'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Spirometry data : Slow Vital Capacity'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Spirometry data : Maximal Inspiratory Pressure'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Spirometry data : Maximal Exhalation Pressure'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Weight'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Percentage of weight loss'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Oxymetry'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Non-Invasive Ventilation implementation (yes or no)'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Gastrostomy implementation (yes or no)'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'At inclusion', 'description': 'Survival'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'MRC (Medical Research Council) scale for the evaluation of muscular strength. Score from 0 to 5. Higher score means normal movement'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating) scale score. Score from 0 to 48.'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Spirometry data : Slow Vital Capacity'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Spirometry data : Maximal Inspiratory Pressure'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Spirometry data : Maximal Exhalation Pressure'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Weight'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Percentage of weight loss'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Oximetry'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Non-Invasive Ventilation Implementation (yes or no)'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Gastrostomy implementation (yes or no)'}, {'measure': 'Clinical and paraclinical likely course data', 'timeFrame': 'Every 3 months up to 2 years', 'description': 'Survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quadriceps Combined Test', 'Amyotrophic Lateral Sclerosis'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Able to give informed consent to participate in the research\n* Enrolled in a Social Security plan\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Severe progressive pathology other than ALS.\n* Comorbidities with another neurological disease altering motor skills.\n* Contraindication to trans-cranial magnetic stimulation: epilepsy, pacemaker, intracranial ferromagnetic foreign body (clip, aneurysm, implants)...\n* Chronic alcoholism\n* 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)\n* Refusal to participate.\n* Patients under legal protection (guardianship, curators, safeguard of justice)'}, 'identificationModule': {'nctId': 'NCT06284161', 'acronym': 'PEM-SLA', 'briefTitle': 'QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Contribution of the Combined Quadriceps Test (QCT) in the Diagnosis, Mechanistic Understanding and Follow-up of Amyotrophic Lateral Sclerosis', 'orgStudyIdInfo': {'id': 'RBHP 2020 GUY'}, 'secondaryIdInfos': [{'id': '2020-A02765-34', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Quadriceps Combined Test', 'interventionNames': ['Diagnostic Test: Quadriceps Combined Test']}], 'interventions': [{'name': 'Quadriceps Combined Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Motor- Evoked Potentials'], 'description': '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.', 'armGroupLabels': ['Quadriceps Combined Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33473754963'}, {'name': 'Nathalie Guy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33473754963'}], 'overallOfficials': [{'name': 'Nathalie Guy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}