Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-22 @ 7:13 PM
Study NCT ID:
NCT05671068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-10
First Post:
2022-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMOTION & COGNITION in MYOCLONUS DYSTONIA (AGENT10-ECODYST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536096', 'term': 'Myoclonic dystonia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BOLD signal derived from the functional magnetic resonance imaging', 'timeFrame': '46 month', 'description': 'Explore the differences in DYT-SGCE compared to HV'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myoclonus-Dystonia', 'DYT11']}, 'referencesModule': {'references': [{'pmid': '29952836', 'type': 'BACKGROUND', 'citation': 'Roze E, Lang AE, Vidailhet M. Myoclonus-dystonia: classification, phenomenology, pathogenesis, and treatment. Curr Opin Neurol. 2018 Aug;31(4):484-490. doi: 10.1097/WCO.0000000000000577.'}, {'pmid': '26783545', 'type': 'BACKGROUND', 'citation': 'Peall KJ, Dijk JM, Saunders-Pullman R, Dreissen YE, van Loon I, Cath D, Kurian MA, Owen MJ, Foncke EM, Morris HR, Gasser T, Bressman S, Asmus F, Tijssen MA. Psychiatric disorders, myoclonus dystonia and SGCE: an international study. Ann Clin Transl Neurol. 2015 Nov 20;3(1):4-11. doi: 10.1002/acn3.263. eCollection 2016 Jan.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nMyoclonus dystonia (DYT-SGCE) is characterized by myoclonus and dystonia. Such condition is associated with a high prevalence of psychiatric symptoms which are part of the phenotype. The mechanisms underlying these non-motor symptoms are still poorly understood.\n\nObjective:\n\nTo investigate the neural correlates of cognition and emotion in DYT-SGCE.\n\nDesign:\n\nParticipants will have 1 - 2 visits at the clinical center. The total participation time is less than 24 hours.\n\nParticipants will have a medical interview and a neurological exam. They may give a urine sample before MRI.\n\nParticipants will have a short neuropsychologic and psychiatric interviews. Participants will have MRI scans. They will do small tasks or be asked to imagine things during the scanning.', 'detailedDescription': 'Eligibility:\n\nDYT-SGCE patients and healthy volunteers (HV) between 15 and 60 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll patients with DYT-SGCE and Healthy Volunteers (HVs).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all participants:\n\n* Age between 15-60 years\n* Able to give informed consent.\n\nFor patients:\n\n* An established diagnostic of DYT-SGCE\n* No change in medication (related to DYT-SGCE) for a month\n\nFor controls:\n\n* No neurological symptoms\n* No medication except oral contraception\n\nExclusion Criteria:\n\n* No deprivation of liberty\n* Inability to give a consent\n* Established cognitive alteration\n* Contraindication to MRI (per MRI safety checklist)\n* Severe chronic psychiatric illness'}, 'identificationModule': {'nctId': 'NCT05671068', 'briefTitle': 'EMOTION & COGNITION in MYOCLONUS DYSTONIA (AGENT10-ECODYST)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'CEREBELLAR INVOLVEMENT in MOTOR, COGNITIVE and EMOTIONAL PROCESSES in MYOCLONUS DYSTONIA', 'orgStudyIdInfo': {'id': 'C22-18'}, 'secondaryIdInfos': [{'id': '2022-A00786-37', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'DYT-SGCE', 'description': 'Patients with myoclonus dystonia (DYT-SGCE)'}, {'label': 'Healthy volunteers', 'description': 'Control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Brain Institute', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Emmanuel Roze, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of neurology, Pitié-Salpêtrière Hospital, Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}