Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT07290920
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sensorimotor Integration in Patients With 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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of sensory attenuation (difference between self-generated and externally generated force reproduction)', 'timeFrame': 'Day 1', 'description': 'Sensory attenuation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tourette Syndrome', 'Sense of agency', 'Sensorimotor integration', 'Sensory attenuation', 'Motor control', 'Predictive processing'], 'conditions': ['Tourette Disorder', 'Sensory Gating']}, 'referencesModule': {'references': [{'pmid': '26963083', 'type': 'BACKGROUND', 'citation': 'Delorme C, Salvador A, Voon V, Roze E, Vidailhet M, Hartmann A, Worbe Y. Illusion of agency in patients with Gilles de la Tourette Syndrome. Cortex. 2016 Apr;77:132-140. doi: 10.1016/j.cortex.2016.02.003. Epub 2016 Feb 17.'}, {'pmid': '32937445', 'type': 'BACKGROUND', 'citation': 'Zapparoli L, Seghezzi S, Zirone E, Guidali G, Tettamanti M, Banfi G, Bolognini N, Paulesu E. How the effects of actions become our own. Sci Adv. 2020 Jul 1;6(27):eaay8301. doi: 10.1126/sciadv.aay8301. Print 2020 Jul.'}, {'pmid': '23744445', 'type': 'BACKGROUND', 'citation': 'Brown H, Adams RA, Parees I, Edwards M, Friston K. Active inference, sensory attenuation and illusions. Cogn Process. 2013 Nov;14(4):411-27. doi: 10.1007/s10339-013-0571-3. Epub 2013 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'The present study investigates the mechanisms underlying the sense of agency in patients with Tourette Syndrome (TS). Previous research has shown that individuals with TS display impairments in both explicit and implicit aspects of agency, possibly due to altered integration between sensory feedback and motor predictions. To explore this hypothesis, the study will examine the phenomenon of sensory attenuation, a marker of sensorimotor integration that has not yet been investigated in this population. Furthermore, the study will assess how alterations in sensorimotor integration are related to the severity of TS symptoms.', 'detailedDescription': "The present study aims to investigate the mechanisms underlying the sense of agency in patients with Tourette Syndrome (TS). Previous evidence indicates that individuals with TS exhibit abnormalities in both explicit and implicit (absent intentional binding) experiences of agency. According to a recent theoretical framework, such alterations may stem from impaired sensorimotor integration - specifically, a dysfunction in the ability to combine sensory feedback with motor predictions about the consequences of one's own actions. This deficit may not only affect motor control but also the awareness of self-generated movements, thereby compromising the distinction between self-produced and externally produced actions.\n\nTo test this hypothesis, the study will employ the Force Matching Task (FMT), a well-established paradigm used to assess sensory attenuation - the reduced perception of intensity for self-generated sensations compared to externally generated ones. In this task, participants are asked to reproduce a force applied to their finger either by pressing directly with their own finger (self-generated condition) or by controlling a mechanical device (externally generated condition). In healthy individuals, self-generated forces are typically perceived as weaker due to predictive motor mechanisms. A reduced or absent sensory attenuation effect would indicate altered sensorimotor integration.\n\nThe primary aim of the study is therefore to evaluate whether patients with Tourette Syndrome show atypical sensory attenuation compared to healthy controls, as an index of altered sensorimotor integration underlying the sense of agency. The secondary aim is to examine the relationship between the degree of sensory attenuation and clinical symptom severity, to determine whether deficits in sensorimotor integration are associated with the intensity of tic expression or other clinical features of the disorder."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adult participants aged 18 to 65 years, comprising two groups: individuals diagnosed with Tourette Syndrome (TS) and healthy control participants. The Tourette group will consist of patients meeting DSM-5 diagnostic criteria for Tourette Syndrome, recruited through specialized neurological and neuropsychiatric clinics. Healthy controls will be recruited from the general population and will be matched to the TS group for age, sex, and education level.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Tourette Syndrome group:\n\n* Clinical diagnosis of Tourette Syndrome (TS) according to DSM-5 criteria\n* Age between 18 and 65 years\n* Ability to understand and comply with study procedures\n* Written informed consent provided\n\nFor Healthy Control group:\n\n* No current or past history of neurological or psychiatric disorders\n* Age between 18 and 65 years\n* Matched to the TS group for age, sex, and education level\n* Ability to understand and comply with study procedures\n* Written informed consent provided\n\nExclusion Criteria:\n\n* History of significant neurological disorders (e.g., brain injury or dementia) or major psychiatric disorders (with the exception of conditions commonly associated with Tourette Syndrome, such as Obsessive-Compulsive Disorder, ADHD, depression, and anxiety);\n* Failure or refusal to provide written informed consent;\n* Confirmed pregnancy (self-reported) and/or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07290920', 'acronym': 'ISM', 'briefTitle': 'Sensorimotor Integration in Patients With Tourette Syndrome', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Sensorimotor Integration in Patients With Tourette Syndrome: an Observational Study.', 'orgStudyIdInfo': {'id': 'ISM_L3053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tourette Syndrome Patients', 'description': 'Patients affected by Tourette Syndrome'}, {'label': 'Healthy controls', 'description': 'Individuals without neurological or psychiatric disorders'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': "IRCCS Ospedale Galeazzi-Sant'Ambrogio", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}