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Combined tDCS and TMS on Subjective Tinnitus and Combined Depression

Primary Purpose

Tinnitus, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, tDCS, TMS

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital

Exclusion Criteria:

  • psychoactive drug user
  • implanted material
  • pacemaker user

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    TMS + tDCS group

    sham TMS + tDCS group

    tDCS group

    TMS group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Tinnitus handicap inventory
    tinnitus-related questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    February 6, 2020
    Last Updated
    February 7, 2020
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04262050
    Brief Title
    Combined tDCS and TMS on Subjective Tinnitus and Combined Depression
    Official Title
    The Effect of Combination Transcranial Direct Current Stimulation and Transcranial Magnetic Stimulation on Subjective Tinnitus and Combined Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    July 1, 2018 (Actual)
    Study Completion Date
    July 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus.
    Detailed Description
    To treat motor and psychiatric disorders, transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are world-widely in use in clinics. The investigators combined these two types of neuromodulation techniques to increase the effective response of a single session of neuromodulation in subjective tinnitus. Experimental groups with 80 tinnitus subjects consisted of four different treatment groups which are tDCS, tDCS with sham TMS, tDCS-TMS and TMS group. Subjects were given 1.5milliampere (mA) tDCS on the bi-frontal area and TMS stimulated contralateral single side of the temporoparietal cortex with 200 pulses at 1herz (Hz) stimulation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus, Depression
    Keywords
    Tinnitus, tDCS, TMS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TMS + tDCS group
    Arm Type
    Experimental
    Arm Title
    sham TMS + tDCS group
    Arm Type
    Experimental
    Arm Title
    tDCS group
    Arm Type
    Experimental
    Arm Title
    TMS group
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)
    Primary Outcome Measure Information:
    Title
    Tinnitus handicap inventory
    Description
    tinnitus-related questionnaire
    Time Frame
    the same 1 day after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital Exclusion Criteria: psychoactive drug user implanted material pacemaker user

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Combined tDCS and TMS on Subjective Tinnitus and Combined Depression

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