Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 1:58 PM
Study NCT ID:
NCT04565132
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HD-tDCS as a Treatment for Chronic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Tinnitus Functional Index (TFI)', 'timeFrame': 'Baseline (before intervention), immediately post intervention, 7 weeks follow-up', 'description': 'Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analogue scale (VAS) for tinnitus loudness', 'timeFrame': 'Baseline (before intervention), immediately post intervention, 7 weeks follow-up', 'description': 'Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus'}, {'measure': 'Change in Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline (before intervention), immediately post intervention, 7 weeks follow-up', 'description': 'Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder. Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus'}, {'measure': 'Change in Tinnitus Questionnaire (TQ)', 'timeFrame': 'Baseline (before intervention), immediately post intervention, 7 weeks follow-up', 'description': 'Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus'}, {'measure': 'Change in Hyperacusis Questionnaire (HQ)', 'timeFrame': 'Baseline (before intervention), immediately post intervention, 7 weeks follow-up', 'description': 'Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tinnitus', 'neuromodulation', 'non-invasive brain stimulation', 'transcranial direct current stimulation', 'large cohort', 'high-definition tDCS'], 'conditions': ['Tinnitus, Subjective']}, 'referencesModule': {'references': [{'pmid': '30019630', 'type': 'BACKGROUND', 'citation': 'Jacquemin L, Shekhawat GS, Van de Heyning P, Mertens G, Fransen E, Van Rompaey V, Topsakal V, Moyaert J, Beyers J, Gilles A. Effects of Electrical Stimulation in Tinnitus Patients: Conventional Versus High-Definition tDCS. Neurorehabil Neural Repair. 2018 Aug;32(8):714-723. doi: 10.1177/1545968318787916. Epub 2018 Jul 18.'}, {'pmid': '26180052', 'type': 'BACKGROUND', 'citation': 'Shekhawat GS, Sundram F, Bikson M, Truong D, De Ridder D, Stinear CM, Welch D, Searchfield GD. Intensity, Duration, and Location of High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief. Neurorehabil Neural Repair. 2016 May;30(4):349-59. doi: 10.1177/1545968315595286. Epub 2015 Jul 15.'}, {'pmid': '29127483', 'type': 'BACKGROUND', 'citation': 'Shekhawat GS, Vanneste S. High-definition transcranial direct current stimulation of the dorsolateral prefrontal cortex for tinnitus modulation: a preliminary trial. J Neural Transm (Vienna). 2018 Feb;125(2):163-171. doi: 10.1007/s00702-017-1808-6. Epub 2017 Nov 10.'}, {'pmid': '35666538', 'type': 'DERIVED', 'citation': 'Cardon E, Jacquemin L, Schecklmann M, Langguth B, Mertens G, Vanderveken OM, Lammers M, Van de Heyning P, Van Rompaey V, Gilles A. Random Forest Classification to Predict Response to High-Definition Transcranial Direct Current Stimulation for Tinnitus Relief: A Preliminary Feasibility Study. Ear Hear. 2022 Nov-Dec 01;43(6):1816-1823. doi: 10.1097/AUD.0000000000001246. Epub 2022 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic, subjective, non-pulsatile tinnitus\n* met the criteria for HD-tDCS safety\n\nExclusion Criteria:\n\n* a middle ear pathology\n* another tinnitus treatment ongoing'}, 'identificationModule': {'nctId': 'NCT04565132', 'briefTitle': 'HD-tDCS as a Treatment for Chronic Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study', 'orgStudyIdInfo': {'id': 'HDtDCS_extensive'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HD-tDCS', 'description': 'Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC.', 'interventionNames': ['Device: High Definition transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'High Definition transcranial Direct Current Stimulation', 'type': 'DEVICE', 'description': '1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)', 'armGroupLabels': ['HD-tDCS']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universiteit Antwerpen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}