Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT05871294
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000161', 'term': 'Acoustic Stimulation'}, {'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055909', 'term': 'Magnetic Field Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-14', 'studyFirstSubmitDate': '2023-04-22', 'studyFirstSubmitQcDate': '2023-05-14', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'THI', 'timeFrame': 'Baseline', 'description': 'the scores of tinnitus handicap inventory（0-100）'}, {'measure': 'THI', 'timeFrame': 'within 7 days of treatment completion', 'description': 'the scores of tinnitus handicap inventory（0-100）'}, {'measure': 'THI', 'timeFrame': 'follow-up for 1 month after treatment completion', 'description': 'the scores of tinnitus handicap inventory（0-100）'}, {'measure': 'VAS', 'timeFrame': 'Baseline', 'description': 'Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10'}, {'measure': 'VAS', 'timeFrame': 'within 7 days of treatment completion', 'description': 'Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10'}, {'measure': 'VAS', 'timeFrame': 'follow-up for 1 month after treatment completion', 'description': 'Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinnitus, Subjective', 'Acoustic Stimulation', 'Transcranial Magnetic Stimulation, Repetitive', 'Magnetoencephalography']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to search for biomarkers in tinnitus patients in tinnitus patients and changes in biomarkers before and after treatment. The main questions it aims to answer are:\n\n* What are the biomarkers of tinnitus patients？\n* How do these biomarkers change during treatment and is there a good correlation with behavioral outcomes? Participants will be asked to complete audiological examination, tinnitus assessment, and magnetoencephalography examination, and they will receive sound therapy or repetitive transcranial magnetic stimulation therapy.', 'detailedDescription': 'This study aims to use magnetoencephalography (MEG) to collect the resting state responses before and after treatment in the control group, tinnitus patients in the acoustic stimulation treatment group, and rTMS treatment group. Firstly, compare the differences in power spectrum and brain functional connectivity indicators between tinnitus patients and normal control groups in different frequency bands, providing a theoretical basis for clinical diagnosis, precise positioning of tinnitus damaged areas, and understanding the pathogenesis of tinnitus; Secondly, compare the electrophysiological functional indicators of tinnitus patients before and after treatment to reveal whether the damaged brain network can gradually reshape after treatment, and whether network information can serve as potential biomarkers to indicate the degree of tinnitus recovery; Finally, compare the effectiveness differences between the two treatment methods, analyze their influencing factors, and provide guidance for frequency band precise intervention and rehabilitation of chronic tinnitus patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjective tinnitus lasting for more than 6 months, with a score of\\>36 of the Tinnitus Disability Inventory (THI)；\n2. The otoscopy examination showed that the ear canal and eardrum were normal, and the tympanic impedance maps of both ears were Type A, indicating that language ability met the requirements of language testing\n\nExclusion Criteria:\n\n1. Family or congenital deafness history, ototoxicity drug use history, otitis media patients, etc\n2. Suffering from major physical diseases (sensory and motor disorders, neurological disorders, brain injuries, and other organic diseases) or mental disorders\n3. The patient has aggressive behavior and an impulse to damage the device\n4. Metal in the body (including orthodontics, dental implants), tattoos, and heart stent surgery\n5. Having claustrophobia\n6. Contraindications to magnetic resonance examination'}, 'identificationModule': {'nctId': 'NCT05871294', 'briefTitle': 'Cohort Study on Biomarkers and Clinical Treatment of Tinnitus', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Cohort Study on Biomarkers and Clinical Treatment of Tinnitus', 'orgStudyIdInfo': {'id': 'SH9H-2022-T379-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acoustic stimulation therapy', 'description': 'Patients in this group will receive acoustic stimulation therapy.', 'interventionNames': ['Device: Acoustic stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Repetitive transcranial magnetic stimulation therapy', 'description': 'Patients in this group will receive repetitive transcranial magnetic stimulation therapy.', 'interventionNames': ['Device: Repetitive transcranial magnetic stimulation']}], 'interventions': [{'name': 'Acoustic stimulation', 'type': 'DEVICE', 'description': "The sound used for treatment is selected based on the patient's tinnitus frequency and loudness. Patients receive 90 minutes of acoustic stimulation therapy every day (at least 5 days per week). The entire treatment period is 3 months.", 'armGroupLabels': ['Acoustic stimulation therapy']}, {'name': 'Repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'The course of repeated transcranial magnetic stimulation therapy is 4 weeks, with 5, 5, 4, and 3 treatments per week, each lasting 90 minutes (including rest time)', 'armGroupLabels': ['Repetitive transcranial magnetic stimulation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiwu Huang, Professor', 'role': 'CONTACT', 'email': 'huangzw086@163.com', 'phone': '18964331112'}, {'name': 'Qian Zhou', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhiwu Huang', 'role': 'CONTACT', 'email': 'huangzw086@163.com', 'phone': '18964331112'}], 'overallOfficials': [{'name': 'Zhiwu Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhiwu Huang, Ph.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, PHD, Director of the Hearing Center', 'investigatorFullName': 'Zhiwu Huang, Ph.D.', 'investigatorAffiliation': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}}}}