Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-03 @ 11:44 PM
Study NCT ID:
NCT03694132
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2018-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Excitability and Connectivity in Sensory-motor Pathways in ALS
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': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patients vs. health subjects'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain activity', 'timeFrame': '1 hour', 'description': 'Brain parametric maps'}], 'secondaryOutcomes': [{'measure': 'Brain connectivity', 'timeFrame': '15 min', 'description': 'diffusion brain MRI (tractography)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain excitability', 'Brain connectivity', 'Motor cortex', 'Somatosensory cortex'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '29317192', 'type': 'BACKGROUND', 'citation': 'Sangari S, Giron A, Marrelec G, Pradat PF, Marchand-Pauvert V. Abnormal cortical brain integration of somatosensory afferents in ALS. Clin Neurophysiol. 2018 Apr;129(4):874-884. doi: 10.1016/j.clinph.2017.12.008. Epub 2017 Dec 24.'}, {'pmid': '40488178', 'type': 'RESULT', 'citation': 'Benetton C, Preuilh A, Khamaysa M, Chaumon M, Lackmy-Vallee A, Er A, Pelegrini-Issac M, Querin G, Rouaux C, Pradat PF, Marchand-Pauvert V. Encephalography cross-frequency coupling and brain alteration in amyotrophic lateral sclerosis. Brain Commun. 2025 Jun 6;7(3):fcaf192. doi: 10.1093/braincomms/fcaf192. eCollection 2025.'}], 'seeAlsoLinks': [{'url': 'https://hal.science/hal-04497572v1/file/ISBI24_paper_414.pdf', 'label': 'This paper reports results'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to determine the origin of somatosensory alteration in patients with ALS and to evaluate its impact on brain activity by coupling different imaging modalities and indirect electrophysiology.\n\nThe secondary objective is to evaluate whether the observed functional changes in MEG / EEG and functional MRI correlate with structural lesions revealed with diffusion MRI (anatomo-functional connectivity of the brain).', 'detailedDescription': 'Somatosensory evoked potentials (SEPs) produced by ulnar nerve electrical stimulation will be collected with combined MEG and EGG.\n\nFunctional MRI will be performed during electrical stimulation of ulnar nerve and during mechanical vibration of ADM tendon.\n\nBrain diffusion MRI will be performed. Anatomical MRI will be done for source location. Brain resting state activity will be recorded with MEG/EEG and fMRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'controls will be gender and age-matched to ALS', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALS, MRC score ≥ 4 at least in one hand\n* Controls: no history of neurological disorders, right-handed\n\nExclusion Criteria:\n\n* contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT03694132', 'acronym': 'SOM_ALS', 'briefTitle': 'Brain Excitability and Connectivity in Sensory-motor Pathways in ALS', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology', 'orgStudyIdInfo': {'id': 'C17-70'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'functional MRI', 'description': 'a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical and mechanical stimuli of ADM proprioceptors', 'interventionNames': ['Device: functional MRI']}, {'type': 'EXPERIMENTAL', 'label': 'structural MRI', 'description': 'a group of patients with ALS and a group of gender and age matched healthy subjects will have diffusion MRI acquisition to evaluate their brain structures', 'interventionNames': ['Device: structural MRI']}, {'type': 'EXPERIMENTAL', 'label': 'EEG/MEG', 'description': 'a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical stimuli of ADM proprioceptors', 'interventionNames': ['Device: EEG/MEG']}], 'interventions': [{'name': 'functional MRI', 'type': 'DEVICE', 'description': 'conditioning brain activity with peripheral stimulations', 'armGroupLabels': ['functional MRI']}, {'name': 'structural MRI', 'type': 'DEVICE', 'description': 'diffusion MRI and tractography for evaluating the brain structures', 'armGroupLabels': ['structural MRI']}, {'name': 'EEG/MEG', 'type': 'DEVICE', 'description': 'conditioning brain activity with peripheral stimulations', 'armGroupLabels': ['EEG/MEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre-Francois Pradat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Veronique Marchand-Pauvert, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}