Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT01075061
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2010-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC "
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- To unravel the pathophysiology of congenital mirror movements - To identify a locus and candidate genes associated with CMM', 'timeFrame': '08/2011'}], 'secondaryOutcomes': [{'measure': '- To study patients with Kallmann syndrome and associated MM based on the same methods and hypothesis', 'timeFrame': '08/2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congenital mirror movement, physiopathology, imaging, transcranial magnetic stimulation, candidate gene'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '21242494', 'type': 'BACKGROUND', 'citation': 'Depienne C, Cincotta M, Billot S, Bouteiller D, Groppa S, Brochard V, Flamand C, Hubsch C, Meunier S, Giovannelli F, Klebe S, Corvol JC, Vidailhet M, Brice A, Roze E. A novel DCC mutation and genetic heterogeneity in congenital mirror movements. Neurology. 2011 Jan 18;76(3):260-4. doi: 10.1212/WNL.0b013e318207b1e0.'}]}, 'descriptionModule': {'briefSummary': 'Mirror movements are involuntary, symmetrical and simultaneous movements occurring on one side of the body that accompany controlateral voluntary movements. Congenital mirror movements (CMM) are characterized by childhood onset and the absence of additional manifestations. The aim of this study is to unravel the pathophysiology of the CMM that remains poorly elucidated. The combination of imaging studies and neurophysiological studies using transcranial magnetic stimulation in a homogeneous and relatively large group of patient is likely to allow us to better understand the underlying pathophysiology of the disorder. Using a linkage analysis approach we will try to identify a locus associated with CMM and related candidate genes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 11 to 82 years\n* Members of the family of interest displaying mirror movements or being obligatory asymptomatic carrier, without additional manifestation or malformation; or patient with genetically proven Kallmann syndrome and mirror movements.\n* No contraindication for MRI or TMS study\n\nExclusion Criteria:\n\n* inability to provide an informed consent\n* Simultaneous participation in another clinical trial\n* Treatment that modulate cortical excitability (for the TMS part of the study only)'}, 'identificationModule': {'nctId': 'NCT01075061', 'acronym': 'MOMIC', 'briefTitle': 'Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC "', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification : MOMIC', 'orgStudyIdInfo': {'id': 'C09-06'}, 'secondaryIdInfos': [{'id': '2009-A00490-57', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'healthy volunteers', 'description': 'healthy volunteers', 'interventionNames': ['Other: healthy volunteers']}, {'type': 'OTHER', 'label': 'Kallmann', 'description': 'Kallmann syndrome patients', 'interventionNames': ['Other: Kallmann']}, {'type': 'OTHER', 'label': 'Congenital Mirror Movement', 'description': 'patients with CMM', 'interventionNames': ['Other: Congenital Mirror Movement']}], 'interventions': [{'name': 'healthy volunteers', 'type': 'OTHER', 'description': 'morphological and functional brain MRI; transcranial magnetic stimulation', 'armGroupLabels': ['healthy volunteers']}, {'name': 'Kallmann', 'type': 'OTHER', 'description': 'morphological and functional brain MRI; transcranial magnetic stimulation', 'armGroupLabels': ['Kallmann']}, {'name': 'Congenital Mirror Movement', 'type': 'OTHER', 'description': 'morphological and functional brain MRI; transcranial magnetic stimulation', 'armGroupLabels': ['Congenital Mirror Movement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Fédération des Maladies du Système Nerveux, Hôpital Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Emmanuel ROZE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}