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HD-tDCS as a Treatment for Chronic Tinnitus

Primary Purpose

Tinnitus, Subjective

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Definition transcranial Direct Current Stimulation
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective focused on measuring tinnitus, neuromodulation, non-invasive brain stimulation, transcranial direct current stimulation, large cohort, high-definition tDCS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic, subjective, non-pulsatile tinnitus
  • met the criteria for HD-tDCS safety

Exclusion Criteria:

  • a middle ear pathology
  • another tinnitus treatment ongoing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HD-tDCS

    Arm Description

    Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC.

    Outcomes

    Primary Outcome Measures

    Change in Tinnitus Functional Index (TFI)
    Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus

    Secondary Outcome Measures

    Change in Visual Analogue scale (VAS) for tinnitus loudness
    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
    Change in Hospital Anxiety and Depression Scale (HADS)
    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
    Change in Tinnitus Questionnaire (TQ)
    Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus
    Change in Hyperacusis Questionnaire (HQ)
    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.

    Full Information

    First Posted
    August 12, 2020
    Last Updated
    September 24, 2020
    Sponsor
    University Hospital, Antwerp
    Collaborators
    Universiteit Antwerpen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04565132
    Brief Title
    HD-tDCS as a Treatment for Chronic Tinnitus
    Official Title
    High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 21, 2016 (Actual)
    Primary Completion Date
    April 8, 2019 (Actual)
    Study Completion Date
    April 9, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Antwerp
    Collaborators
    Universiteit Antwerpen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus, Subjective
    Keywords
    tinnitus, neuromodulation, non-invasive brain stimulation, transcranial direct current stimulation, large cohort, high-definition tDCS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    117 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HD-tDCS
    Arm Type
    Experimental
    Arm Description
    Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC.
    Intervention Type
    Device
    Intervention Name(s)
    High Definition transcranial Direct Current Stimulation
    Intervention Description
    1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)
    Primary Outcome Measure Information:
    Title
    Change in Tinnitus Functional Index (TFI)
    Description
    Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus
    Time Frame
    Baseline (before intervention), immediately post intervention, 7 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Change in Visual Analogue scale (VAS) for tinnitus loudness
    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
    Time Frame
    Baseline (before intervention), immediately post intervention, 7 weeks follow-up
    Title
    Change in Hospital Anxiety and Depression Scale (HADS)
    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
    Time Frame
    Baseline (before intervention), immediately post intervention, 7 weeks follow-up
    Title
    Change in Tinnitus Questionnaire (TQ)
    Description
    Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus
    Time Frame
    Baseline (before intervention), immediately post intervention, 7 weeks follow-up
    Title
    Change in Hyperacusis Questionnaire (HQ)
    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.
    Time Frame
    Baseline (before intervention), immediately post intervention, 7 weeks follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic, subjective, non-pulsatile tinnitus met the criteria for HD-tDCS safety Exclusion Criteria: a middle ear pathology another tinnitus treatment ongoing

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30019630
    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.
    Results Reference
    background
    PubMed Identifier
    26180052
    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.
    Results Reference
    background
    PubMed Identifier
    29127483
    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.
    Results Reference
    background

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    HD-tDCS as a Treatment for Chronic Tinnitus

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