Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2026-01-26 @ 11:26 PM
Study NCT ID:
NCT04197804
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2018-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impulse Control in Gilles de la Tourette Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005879', 'term': 'Tourette Syndrome'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013981', 'term': 'Tic Disorders'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2018-12-29', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tourette syndrome and the imitation of gestures', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The aim is to investigate the correlation between Mirror Neurons and Tourette Syndrome defining the greater propensity of the Tourettian subjects to imitate gestures, through the administration of the first Task'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tourette Syndrome']}, 'descriptionModule': {'briefSummary': "The study intends to evaluate the role of Mirror Neurons in the determination of gestures, words, and repetitive vocalizations in subjects affected by Tourette's syndrome and to verify if these subjects are faster to assemble sounds, in phonology and morphology, than the non-pathological population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The calculated sample size is 20 subjects per arm considering:\n\n1. error of I type with two queues = 0.05;\n2. Type II error β = 0.20, which corresponds to a test power (1-β = 0.80) of 80%;\n3. a clinically significant difference of 4%;', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nTOURETTE GROUP\n\n* Consecutive patients belonging to the Tourette Center\n* Caucasian\n* Italian mother-tongue\n* Age between 6 and 10 years completed\n* Male and female 4: 1 (16 males and 4 females)\n* Diagnosis of Tourette's syndrome for at least 1 year\n* Presence of a value of YGTSS\\> 50%\n\nNOT GROUP TOURETTE\n\n* Caucasian\n* Italian mother-tongue\n* Age between 6 and 10 years completed\n* Male and female 4: 1 (16 males and 4 females)\n\nExclusion Criteria:\n\nTOURETTE GROUP\n\n* Diagnosis of DSA\n* Presence of significant psychiatric disorders, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD).\n\nNOT GROUP TOURETTE\n\n* Diagnosis of DSA\n* Presence of significant psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT04197804', 'briefTitle': 'Impulse Control in Gilles de la Tourette Syndrome', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study.', 'orgStudyIdInfo': {'id': 'Nessie (PI: M Porta)'}, 'secondaryIdInfos': [{'id': 'L3035', 'type': 'OTHER_GRANT', 'domain': 'Italian Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tourette group', 'description': '20 subjects with Tourette Syndrome undergoing an evaluation to identify the IQ. Subsequently, 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) concerning the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration of about 3 minutes) concerning the linguistic field.', 'interventionNames': ['Other: Routine tests perform']}, {'label': 'Control group', 'description': '20 subjects without Tourette Syndrome subjected to an evaluation to identify the IQ. Subsequently 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) concerning the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration of about 3 minutes) concerning the linguistic field.', 'interventionNames': ['Other: Routine tests perform']}], 'interventions': [{'name': 'Routine tests perform', 'type': 'OTHER', 'description': 'The subjects of the Tourette group and control group are subjected to routine tests performed at Tourette Center and Extrapyramidal Diseases. Both groups are initially subjected to an evaluation that aims to identify the IQ and therefore 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) related to the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration about 3 minutes) the language field. These evaluations are in practice at the Center for Tourette patients; the tasks will be administered to both groups.', 'armGroupLabels': ['Control group', 'Tourette group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Mauro Porta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Ortopedico Galeazzi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}