Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT05914558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2023-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comorbid Painful TMD Among Trigeminal Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}], 'ancestors': [{'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-06', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence', 'timeFrame': '2 years', 'description': 'Prevalence of comorbid painful TMD among TN patient'}], 'secondaryOutcomes': [{'measure': 'Diagnostic questionnaire', 'timeFrame': '2 years', 'description': 'The sensitivity, specificity of the diagnostic questionnaire for TN and TMD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigeminal Neuralgia', 'Temporomandibular Disorder', 'Myofascial Pain', 'Trigeminal Neuropathy']}, 'descriptionModule': {'briefSummary': 'An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.', 'detailedDescription': 'This multi-center prospective observational cohort study aims to investigate the prevalence of comorbid Temporomandibular disorders (TMD) among trigeminal neuralgia (TN) patients. Trigeminal neuralgia patients with active TN status from three clinical sites (University of Minnesota, School of Dentistry, Orofacial Pain Clinic; Mhealth Fairview, Clinical Surgical Center, Neurosurgery Clinic; John Hopkins University, Anesthesiology, and Critical Care Clinic) could enroll in this study voluntary. All the patients will be evaluated by a provider using standard clinical assessment for TN and TMD, along with validated RedCap questionnaires for TN and TMD diagnosis, and be followed up every six months for 1-2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that visited three clinical centers in the study who sought care for their facial pain were diagnosed with trigeminal neuralgia, with active symptoms in the past 30 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients visited the three clinical sites for facial pain\n* Patients diagnosed with trigeminal neuralgia\n* Has active pain symptoms in the past 30 days\n\nExclusion Criteria:\n\n* Non-English speakers\n* Patients with psychiatric disorders that might alter pain perception\n* Adults lack the capacity to provide informed consent.\n* Persons under the age of 18.\n* All vulnerable populations.'}, 'identificationModule': {'nctId': 'NCT05914558', 'acronym': 'TNTMD', 'briefTitle': 'Comorbid Painful TMD Among Trigeminal Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients', 'orgStudyIdInfo': {'id': 'UMN IRB No. 00008873'}, 'secondaryIdInfos': [{'id': 'JHU IRB No. 00388974', 'type': 'OTHER', 'domain': 'John Hopkins Univeristy'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'TN cohort', 'description': 'The patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days.', 'interventionNames': ['Diagnostic Test: Clinical appointment']}], 'interventions': [{'name': 'Clinical appointment', 'type': 'DIAGNOSTIC_TEST', 'description': 'One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.', 'armGroupLabels': ['TN cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, Department of Neurosurgery', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Donald Nixdorf, DDS,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'Qiman Gao, DDS,MS,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'By end of 2024', 'ipdSharing': 'YES', 'description': 'The final results will be shared with all the participants as a summary.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}