Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-13 @ 11:27 PM
Study NCT ID:
NCT01965028
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2013-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Bi-temporal Transcranial Random Noise Stimulation in 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': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-04', 'studyFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Change of tinnitus severity as measured by the Tinnitus Questionnaire', 'timeFrame': 'Week 2'}, {'measure': 'Change of tinnitus severity as measured by the Tinnitus Questionnaire', 'timeFrame': 'Week 4'}, {'measure': 'Change of tinnitus severity as measured by the Tinnitus Questionnaire', 'timeFrame': 'Week 12'}, {'measure': 'Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales', 'timeFrame': 'Week 2'}, {'measure': 'Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales', 'timeFrame': 'Week 4'}, {'measure': 'Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales', 'timeFrame': 'Week 12'}, {'measure': 'Change of depressive symptoms as measured by the Major Depression Inventory', 'timeFrame': 'Week 2'}, {'measure': 'Change of depressive symptoms as measured by the Major Depression Inventory', 'timeFrame': 'Week 4'}, {'measure': 'Change of depressive symptoms as measured by the Major Depression Inventory', 'timeFrame': 'Week 12'}, {'measure': 'Change in quality of life as measured by the WHOQoL-Bref', 'timeFrame': 'Week 2'}, {'measure': 'Change in quality of life as measured by the WHOQoL-Bref', 'timeFrame': 'Week 4'}, {'measure': 'Change in quality of life as measured by the WHOQoL-Bref', 'timeFrame': 'Week 12'}]}, 'conditionsModule': {'keywords': ['tinnitus', 'transcranial random noise stimulation', 'tRNS', 'auditory cortex', 'non-invasive brain stimulation'], 'conditions': ['Chronic Tinnitus']}, 'referencesModule': {'references': [{'pmid': '31439873', 'type': 'DERIVED', 'citation': 'Kreuzer PM, Poeppl TB, Rupprecht R, Vielsmeier V, Lehner A, Langguth B, Schecklmann M. Daily high-frequency transcranial random noise stimulation of bilateral temporal cortex in chronic tinnitus - a pilot study. Sci Rep. 2019 Aug 22;9(1):12274. doi: 10.1038/s41598-019-48686-0.'}]}, 'descriptionModule': {'briefSummary': 'Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.', 'detailedDescription': 'Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. Preliminary data presented on international conferences suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of bothersome, subjective chronic tinnitus\n* Diagnosis: Duration of tinnitus more than 6 months\n\nExclusion Criteria:\n\n* Objective tinnitus\n* Irregular head shap below the electrodes\n* Eczema on the head\n* Treatable cause of the tinnitus\n* Involvement in other treatments for tinnitus at the same time\n* Clinically relevant psychiatric comorbidity\n* Clinically relevant unstable internal or neurological comorbidity\n* History of or evidence of significant brain malformation or neoplasm, head injury\n* Cerebral vascular events\n* Neurodegenerative disorder affecting the brain or prior brain surgery\n* Metal objects in and around body that can not be removed\n* Pregnancy\n* Alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT01965028', 'acronym': 'tRNS-tin', 'briefTitle': 'Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus', 'orgStudyIdInfo': {'id': 'Uni-Reg-tRNS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial random noise stimulation (tRNS)', 'description': 'High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4', 'interventionNames': ['Device: Transcranial random noise stimulation (tRNS)']}], 'interventions': [{'name': 'Transcranial random noise stimulation (tRNS)', 'type': 'DEVICE', 'description': 'High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS', 'armGroupLabels': ['Transcranial random noise stimulation (tRNS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Regensburg', 'country': 'Germany', 'facility': 'University of Regensburg - Dept of Psychiatry', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Berthold Langguth, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Berthold Langguth, MD, Ph.D.', 'investigatorAffiliation': 'University of Regensburg'}}}}