Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-01-04 @ 4:28 AM
Study NCT ID:
NCT03361332
Status:
UNKNOWN
Last Update Posted:
2017-12-05
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sense of Agency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-12-19', 'releaseDate': '2019-11-28'}], 'estimatedResultsFirstSubmitDate': '2019-11-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D013981', 'term': 'Tic Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2020-01-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BOLD signal changes', 'timeFrame': 'April 2017 - October 2019', 'description': 'The investigators will measure the changes of the BOLD signal associated with the modification of the sense of agency both in healthy subjects and neurological patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motor Activity', 'Motor Tic Disorders']}, 'descriptionModule': {'briefSummary': 'The ability to recognize of being the actors of the behaviour and its consequences, the so-called "Sense of Agency" (SoA), is a crucial component of self-awareness. One key aspect is the distinction from a mere inference about the causality between an act and its consequences and the sense of being the agent of it. Despite a large number of behavioural studies, there is unsatisfactory evidence on the functional anatomical underpinnings of the SoA and the distinction between causality and the SoA proper. Here, the investigators use an implicit measurement of the SoA and its modulations during fMRI: the intentional binding phenomenon (IB). The ivestigators also study how the SoA and the ensuing neurophysiological correlates are modulated by the presence of a movement disorders, such as Gilles de la Tourette Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy controls and patients with Gilles de la Tourette Syndrome', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age included between 18 and 65 years\n* Right handed\n* No contraindication to the fMRI exam\n\nExclusion Criteria:\n\n* Contraindication to the fMRI exam'}, 'identificationModule': {'nctId': 'NCT03361332', 'acronym': 'SOA', 'briefTitle': 'The Sense of Agency', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Behavioural and Neurofunctional Correlates of the Sense of Agency', 'orgStudyIdInfo': {'id': 'SOA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects', 'interventionNames': ['Other: Behavioral and fMRI']}, {'label': 'Patients with Gilles de la Tourette Syndrome', 'interventionNames': ['Other: Behavioral and fMRI']}], 'interventions': [{'name': 'Behavioral and fMRI', 'type': 'OTHER', 'description': 'Subjects and patients will perform temporal-judgment-tasks (considered an indirect measure of the sense of agency) in an event-related fMRI setting. In the first task, they will hear a sound either caused by a voluntary key press or by the passive displacement of the same finger by the experimenter. Following each trial, subjects will estimate the delay between the finger movement and the subsequent sound, which will be presented at variable latencies after the key press. There will be also control-trials characterized by the active or passive movement with a subsequent sound presented with a delay that excludes causality inferences.', 'armGroupLabels': ['Healthy subjects', 'Patients with Gilles de la Tourette Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Zacchetti', 'role': 'CONTACT', 'email': 'sara.zacchetti@grupposandonato.it', 'phone': '+390266214057'}, {'name': 'Eraldo Paulesu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Galeazzi Orthopedic Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Sara Zacchetti', 'role': 'CONTACT', 'email': 'sara.zacchetti@grupposandonato.it', 'phone': '+390266214057'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-11-28', 'type': 'RELEASE'}, {'date': '2019-12-19', 'type': 'RESET'}], 'unpostedResponsibleParty': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}}}}