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
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, tDCS, TMS
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
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
NCT ID
NCT04262050
First Posted
February 6, 2020
Last Updated
February 7, 2020
Sponsor
Seoul National University Hospital
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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