Combined tDCS and TMS on Subjective Tinnitus and Combined Depression
February 7, 2020 updated by: Jae-Jin Song, Seoul National University Hospital
The Effect of Combination Transcranial Direct Current Stimulation and Transcranial Magnetic Stimulation on Subjective Tinnitus and Combined Depression
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TMS + tDCS group
|
|
|
Experimental: sham TMS + tDCS group
|
|
|
Experimental: tDCS group
|
|
|
Experimental: TMS group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tinnitus handicap inventory
Time Frame: the same 1 day after treatment
|
tinnitus-related questionnaire
|
the same 1 day after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 7, 2020
First Posted (Actual)
February 10, 2020
Study Record Updates
Last Update Posted (Actual)
February 10, 2020
Last Update Submitted That Met QC Criteria
February 7, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1607/355-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.