Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT07259902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FMRI Study on DC/TMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fmri Blood Oxygen Level-Dependent (BOLD)', 'timeFrame': 'end of the fmri', 'description': 'Oxygenation concentration (referred to as BOLD). Bold is primarily used on the other hand to conduct function brain mapping. The degree of BOLD is a measure of the neuronal activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMJ Disorder']}, 'descriptionModule': {'briefSummary': 'Temporomandibular disorders (TMD) are among the most common causes of chronic pain worldwide. It is estimated that about 5-12% of the global population is affected, and some conditions, such as arthritis, may be causative factors. Depending on severity, the joints involved can affect multiple functions of the masticatory system, such as the ability to speak, chew, swallow, limit facial expressions, and even breathe. Moreover, most patients with TMD may report painful conditions in other parts of the body, with comorbidities including chronic fatigue syndrome, chronic headache, endometriosis, fibromyalgia, interstitial cystitis, irritable bowel syndrome, back pain, sleep disorders, and vulvodynia. Another significant condition that frequently occurs alongside TMD is psychological distress in the form of anxiety and/or depression.\n\nThe study proposed by this research protocol aims to investigate the presence of TMD and associated psychological/psychiatric disorders such as anxiety and depression. The innovative value of the research lies in evaluating whether the association between these disorders may lead to neuroplastic changes at the brain level, which could guide targeted therapies. Only a few studies in the literature have explored this possible association, with inconclusive and conflicting results.\n\nThe study will be prospective in design, based on reference clinical/diagnostic criteria and functional neuroimaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Afflicted with temporomandibular disorder (TMD) associated with chronic pain diagnosed by an experienced specialist among the authors; the disorder, to be considered chronic, must have been present for at least six months.\n* Patients with adequate sensorimotor abilities to participate in the study. This included sufficient vision to read from a computer or tablet screen at a normal distance, sufficient hearing ability to understand normal language, and sufficient motor ability to control a table mouse or computer.\n\nExclusion Criteria:\n\n* Control subjects, participating voluntarily in the study, must have met the following inclusion criteria:\n* Healthy subjects defined as free from temporomandibular disorders or diagnosed psychological and/or psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT07259902', 'briefTitle': 'FMRI Study on DC/TMD Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Mapping the Neuroplasticity of Patients Affected by Chronic Temporomandibular Disorders on fMRI', 'orgStudyIdInfo': {'id': 'DC/TMD01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study', 'description': 'FMRI', 'interventionNames': ['Diagnostic Test: fMRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'FMRI', 'interventionNames': ['Diagnostic Test: fMRI']}], 'interventions': [{'name': 'fMRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'fMRI morphological analysis', 'armGroupLabels': ['Healthy controls', 'study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Gianluca M Tartaglia', 'role': 'CONTACT', 'email': 'gio.cat@hotmail.it', 'phone': '+39 02 5032 5032'}, {'name': 'Marco Farronato, DDS; PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giovanni Cattaneo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Milan', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Gianluca Tartaglia GMT Tartaglia', 'role': 'CONTACT', 'email': 'gio.cat@hotmail.it', 'phone': '+39 02 5032 5032'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CO-Principal Investigator', 'investigatorFullName': 'Marco Farronato', 'investigatorAffiliation': 'University of Milan'}}}}