Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00668720
Status:
COMPLETED
Last Update Posted:
2011-06-30
First Post:
2008-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation (rTMS) for 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': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-29', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-25', 'lastUpdatePostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus severity with the Tinnitus Questionnaire', 'timeFrame': 'after treatment, 1 week, 1, 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Tinnitus Handicap Inventory', 'timeFrame': 'after treatment, 1 week, 1, 3 and 6 months'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'after treatment, 1 week, 1, 3 and 6 months'}, {'measure': 'State Trait Anxiety Index', 'timeFrame': 'after treatment, 1 week, 1, 3 and 6 months'}, {'measure': 'Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.', 'timeFrame': 'for the first three months daily and for the second three months monthly'}, {'measure': 'Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)', 'timeFrame': '1 week after treatment and after 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tinnitus', 'transcranial magnetic stimulation'], 'conditions': ['Tinnitus']}, 'referencesModule': {'references': [{'pmid': '24157459', 'type': 'DERIVED', 'citation': 'Hoekstra CE, Versnel H, Neggers SF, Niesten ME, van Zanten GA. Bilateral low-frequency repetitive transcranial magnetic stimulation of the auditory cortex in tinnitus patients is not effective: a randomised controlled trial. Audiol Neurootol. 2013;18(6):362-73. doi: 10.1159/000354977. Epub 2013 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.\n* Age ≥18 years\n* Dutch speaking\n\nExclusion Criteria:\n\n* Treatable cause of the tinnitus\n* Use of anticonvulsant medication or other psychotherapeutic drugs\n* History of epilepsy or family members with epilepsy\n* Presence of active migraine\n* Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy\n* Metal objects in and around body that can not be removed\n* Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)\n* Alcohol or drug abuse\n* Prior treatment with TMS'}, 'identificationModule': {'nctId': 'NCT00668720', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus', 'orgStudyIdInfo': {'id': 'rTMS_tinnitus_Utrecht'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: transcranial magnetic stimulation (Magstim rapid2)']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'interventionNames': ['Device: sham stimulation']}], 'interventions': [{'name': 'transcranial magnetic stimulation (Magstim rapid2)', 'type': 'DEVICE', 'otherNames': ['Magstim rapid2'], 'description': 'Neuronavigated rTMS will be applied bilaterally to the auditory cortices, which will be identified through a structural MRI scan. Stimulation will be performed with 1 Hz frequency and an intensity of 110% motor threshold for 2000 stimuli (32 minutes) on each side, on five subsequent days.', 'armGroupLabels': ['1']}, {'name': 'sham stimulation', 'type': 'DEVICE', 'description': 'The official sham stimulator for the magstim rapid2 will be used. Sham stimulation will follow the same placement protocol and will also last 2x32 minutes on five subsequent days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Bert A van Zanten, AuD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Otorhinolaryngology, University Medical Center Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'dr. G.A. van Zanten', 'oldOrganization': 'Department of Otorhinolaryngology, University Medical Center Utrecht'}}}}