Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT03351218
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2017-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Agency in Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020821', 'term': 'Dystonic Disorders'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups study : patients versus healthy controls'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2017-10-10', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'agency tasks behavioral outcome measures', 'timeFrame': 'throughout study completion, an average 2 years', 'description': 'response time'}, {'measure': 'agency tasks behavioral outcome measures', 'timeFrame': 'throughout study completion, an average 2 years', 'description': 'response accuracy in tasks trials'}], 'secondaryOutcomes': [{'measure': 'MRI measures', 'timeFrame': 'throughout study completion, an average 2 years', 'description': 'cortical thickness'}, {'measure': 'MRI measures', 'timeFrame': 'throughout study completion, an average 2 years', 'description': 'basal ganglia volume'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dystonia, Primary']}, 'referencesModule': {'references': [{'pmid': '32960985', 'type': 'RESULT', 'citation': 'Tarrano C, Lamy JC, Delorme C, McGovern EM, Atkinson-Clement C, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Apartis E, Vidailhet M, Roze E, Worbe Y. Tactile Temporal Discrimination Is Impaired in Myoclonus-Dystonia. Mov Disord. 2020 Dec;35(12):2356-2357. doi: 10.1002/mds.28253. Epub 2020 Sep 22. No abstract available.'}, {'pmid': '31571302', 'type': 'RESULT', 'citation': 'Tarrano C, Wattiez N, Delorme C, McGovern EM, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Valabregue R, Vidailhet M, Pouget P, Roze E, Worbe Y. Visual sensory processing is altered in myoclonus dystonia. Mov Disord. 2020 Jan;35(1):151-160. doi: 10.1002/mds.27857. Epub 2019 Sep 30.'}, {'pmid': '34875561', 'type': 'RESULT', 'citation': 'Zito GA, Tarrano C, Jegatheesan P, Ekmen A, Beranger B, Rebsamen M, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Brissard MA, Vidailhet M, Gallea C, Roze E, Worbe Y. Somatotopy of cervical dystonia in motor-cerebellar networks: Evidence from resting state fMRI. Parkinsonism Relat Disord. 2022 Jan;94:30-36. doi: 10.1016/j.parkreldis.2021.11.034. Epub 2021 Nov 30.'}, {'pmid': '37148555', 'type': 'RESULT', 'citation': 'Zito GA, Tarrano C, Ouarab S, Jegatheesan P, Ekmen A, Beranger B, Valabregue R, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Apoil Brissard M, Vidailhet M, Hasboun D, Worbe Y, Roze E, Gallea C. Fixel-Based Analysis Reveals Whole-Brain White Matter Abnormalities in Cervical Dystonia. Mov Disord. 2023 Jul;38(7):1187-1196. doi: 10.1002/mds.29425. Epub 2023 May 6.'}, {'pmid': '40910449', 'type': 'RESULT', 'citation': 'Zito GA, Roze E, Tarrano C, Ouarab S, Jegatheesan P, Ekmen A, Beranger B, Valabregue R, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Apoil Brissard M, Vidailhet M, Hasboun D, Pouget P, Worbe Y, Gallea C. Abnormal Connectivity of the Head Neural Integrator in Cervical Dystonia. Mov Disord. 2025 Sep 5. doi: 10.1002/mds.70014. Online ahead of print.'}, {'pmid': '32811896', 'type': 'RESULT', 'citation': 'Atkinson-Clement C, Tarrano C, Porte CA, Wattiez N, Delorme C, McGovern EM, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Valabregue R, Rosso C, Apartis E, Vidailhet M, Pouget P, Roze E, Worbe Y. Dissociation in reactive and proactive inhibitory control in Myoclonus dystonia. Sci Rep. 2020 Aug 18;10(1):13933. doi: 10.1038/s41598-020-70926-x.'}]}, 'descriptionModule': {'briefSummary': 'In this study, using computerized cognitive assessments combined with multi-modal neuroimaging approach investigators aim to address three specific questions on patients with cervical and myoclonus dystonia:\n\n(i) investigate various aspects of the sense of agency and relationship to the severity of dystonia symptoms, (ii) characterize the possible link between abnormalities of movement perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal underpinnings of the defective sense of agency in dystonia.', 'detailedDescription': 'This is a single-centre, two-group ( dystonia and control), case-control study using behavioural and novel multimodal neuroimaging techniques to address the study aims.\n\nThe battery of the tasks will include explicit-agency tasks, a visual discrimination task on objects movement perception. The magnetic resonance acquisition protocol will include MP2RAGE structural (10 min duration), multi echo (3 echo times) multiband (MB factor 4) resting state functional neuroimaging (15 minutes duration) and multi shell diffusion imaging sequence (15 minutes duration)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of isolated adult-onset cervical dystonia (CD) or myoclonus dystonia (MD);\n* duration of disease of more than one year\n* no botulinum toxin injection for at least three months before the study\n* normal or corrected-to-normal vision.\n\nExclusion Criteria\n\n* any neurological history except for dystonia,\n* history of dopamine antagonist treatment,\n* secondary dystonia,\n* dystonia in the upper limbs,\n* inability to maintain gaze straight.'}, 'identificationModule': {'nctId': 'NCT03351218', 'acronym': 'AGENT10', 'briefTitle': 'Agency in Dystonia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Neuronal Correlates of Agency in Dystonia', 'orgStudyIdInfo': {'id': 'C17-04'}, 'secondaryIdInfos': [{'id': '2017-A01231-52', 'type': 'REGISTRY', 'domain': 'RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients', 'description': '25 patients with cervical and 25 patients with myoclonus dystonia', 'interventionNames': ['Behavioral: Behavioral testing - computerized tasks']}, {'type': 'OTHER', 'label': 'Controls', 'description': '50 healthy volunteers matched to patents ( age, sex)', 'interventionNames': ['Behavioral: Behavioral testing - computerized tasks']}], 'interventions': [{'name': 'Behavioral testing - computerized tasks', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral testing and cerebral MRI', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': "Centre d'investigation Clinique", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}