Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-21 @ 6:52 PM
Study NCT ID:
NCT01412918
Status:
TERMINATED
Last Update Posted:
2016-02-29
First Post:
2011-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dfriedland@mcw.edu', 'phone': '414-805-', 'title': 'Dr. David Friedland', 'organization': 'Medical College of Wisconsion'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tinnitus', 'description': 'Individual with tinnitus. Intervention: inhibitor device demonstration.\n\nThe Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Tinnitus', 'description': 'Individuals without tinnitus.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tinnitus', 'description': 'Tinnitus. genetic sample collection (no intervention)'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Single visit (day 1), assessed the day of visit', 'description': 'Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Which Showed Presence of SCN9 Gene Expression.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tinnitus', 'description': 'Individual with tinnitus.\n\nThe Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device'}, {'id': 'OG001', 'title': 'No Tinnitus', 'description': 'Individuals without tinnitus.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Single visit (day 1), evaluated at the time of the genetic collection.', 'description': 'Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.', 'unitOfMeasure': '% of participants with gene expression', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tinnitus', 'description': 'Individual with tinnitus.\n\nThe Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device'}, {'id': 'FG001', 'title': 'No Tinnitus', 'description': 'Individuals without tinnitus.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tinnitus', 'description': 'Individual with tinnitus.\n\nThe Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device'}, {'id': 'BG001', 'title': 'No Tinnitus', 'description': 'Individuals without tinnitus.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline participants with tinnitus demonstrating the Inhibitor™ Tinnitus Masking Device.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Lack of support to continue', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2011-07-06', 'resultsFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception', 'timeFrame': 'Single visit (day 1), assessed the day of visit', 'description': 'Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Which Showed Presence of SCN9 Gene Expression.', 'timeFrame': 'Single visit (day 1), evaluated at the time of the genetic collection.', 'description': 'Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tinnitus', 'Inhibitor Device', 'SCN9 gene', 'Ringing in the ears', 'Milwaukee', 'Medical College of Wisconsin'], 'conditions': ['Tinnitus']}, 'referencesModule': {'references': [{'pmid': '20212137', 'type': 'BACKGROUND', 'citation': 'Reimann F, Cox JJ, Belfer I, Diatchenko L, Zaykin DV, McHale DP, Drenth JP, Dai F, Wheeler J, Sanders F, Wood L, Wu TX, Karppinen J, Nikolajsen L, Mannikko M, Max MB, Kiselycznyk C, Poddar M, Te Morsche RH, Smith S, Gibson D, Kelempisioti A, Maixner W, Gribble FM, Woods CG. Pain perception is altered by a nucleotide polymorphism in SCN9A. Proc Natl Acad Sci U S A. 2010 Mar 16;107(11):5148-53. doi: 10.1073/pnas.0913181107. Epub 2010 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus.', 'detailedDescription': 'Up to 50 million Americans have tinnitus on a regular basis with between 2-3 million suffering from tinnitus where it affects daily living. The Inhibitor™ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitor™ Tinnitus Masking Device. Patients may provide a genetic sample (typically via saliva sample) to look for expression of a particular genetic marker that may be associated with tinnitus. The investigators will be collect samples from both people with tinnitus and those without tinnitus to use as a control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years,\n* has tinnitus\n\nExclusion Criteria:\n\n* Pacemaker,\n* pregnancy,\n* metal implants in head or neck,\n* thrombosis, migraines/headaches,\n* metal bonded retainer, surgeries within the last 6 months which patient is still recovering from,\n* any medical reason your physician would advise against the use of this device,\n* under 18 years'}, 'identificationModule': {'nctId': 'NCT01412918', 'briefTitle': 'Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression', 'orgStudyIdInfo': {'id': 'PRO00014763'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tinnitus', 'description': 'Individual with tinnitus. Intervention: inhibitor device demonstration.\n\nThe Inhibitor™ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitor™ Tinnitus Masking Device.', 'interventionNames': ['Device: The Inhibitor™ Tinnitus Masking Device']}, {'type': 'NO_INTERVENTION', 'label': 'No tinnitus', 'description': 'Individuals without tinnitus will also be masked with the device.'}], 'interventions': [{'name': 'The Inhibitor™ Tinnitus Masking Device', 'type': 'DEVICE', 'description': 'The Inhibitor™ Tinnitus Masking Device', 'armGroupLabels': ['Tinnitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert & The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'David R Friedland, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marcia Dewey, AuD', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}